FDA-cleared K260729

Vascular Assist Occlusion Triage (VAOT) (v1.0)

GuideAI Health

Passive workflow prioritization for studies with imaging patterns consistent with possible total arterial occlusion in the specified vessels; not primary diagnosis, screening,...

Modality
CT/CTA
Anatomy
Aorta and lower-extremity arteries: common iliac, external iliac, common femoral, superficial femoral, and popliteal arteries
Decision
2026-06-18
FDA-cleared K253825

Saige-Dx

DeepHealth, Inc.

Concurrent detection and characterization support for screening DBT mammography

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-06-15
FDA-cleared K254075

Synapse Lung Nodule AI

Fujifilm Corporation

Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.

Modality
CT/CTA
Anatomy
Chest/lungs; pulmonary nodules
Decision
2026-05-27
FDA-cleared K254131

BAC

DeepHealth, Inc.

BAC processes screening FFDM and DBT mammograms to detect the presence or absence of breast arterial calcifications at study and breast level and localize detected calcifications...

Modality
Mammography/DBT
Anatomy
Breast; breast arterial calcifications
Decision
2026-05-21
FDA-cleared K260234

MSK Go

Smart Alfa Teknoloji San. Ve Tic. A.S.

Assist qualified MSK-ultrasound professionals by highlighting supported joint anatomy and detection completeness on compatible adult ultrasound images; it is not a diagnostic...

Modality
Ultrasound
Anatomy
Musculoskeletal joints: shoulder, elbow, wrist/hand, knee, and ankle/foot.
Decision
2026-05-21
FDA-cleared K252953

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth...

Modality
X-ray/Radiography
Anatomy
Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
Decision
2026-05-11
FDA-cleared K253682

DeepHealth ProstateAI

Quantib B.V.

Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.

Modality
MRI
Anatomy
Prostate and lesions within or extending from the prostate
Decision
2026-04-29
FDA-cleared K260320

Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-04-23
FDA-cleared K253502

Critical Care Suite with Enteric Tube Positioning AI Algorithm

Ge Medical Systems, LLC

Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways...

Modality
X-ray/Radiography
Anatomy
Chest/lung and abdomen/stomach; enteric tube, tube tip and side port, diaphragm, and airways including carina and left/right bronchi
Decision
2026-04-14
FDA-cleared K252190

DeepBT Detector-Plus

Aitewan Biomedical Technology, Inc.

DeepBT Detector-Plus provides initial gross-tumor-volume contours on T1-weighted contrast-enhanced and optional T2-weighted MR images for radiation-treatment planning in adults...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain tumors, including metastases, meningiomas, and acoustic neuromas
Decision
2026-04-10
FDA-cleared K253796

Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems, marking soft-tissue...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-03-26
FDA-cleared K253520

Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, LLC

Photonova Spectra and Spectra Select are silicon-based spectral photon-counting detector CT systems that acquire cross-sectional body images, multienergy data, monochromatic...

Modality
CT/CTA
Anatomy
Head, whole body, heart, vessels, and lungs
Decision
2026-03-20
FDA-cleared K252433

Sonio Detect (v3)

Sonio

Sonio Detect v3 analyzes fetal ultrasound images and clips to detect views and anatomical structures and to check labeled image-quality characteristics during acquisition or...

Modality
Ultrasound
Anatomy
Fetal anatomy
Decision
2026-03-16
FDA-cleared K260166

Bunkerhill Contrast CAC

BunkerHill Health

Detect, localize, and estimate the burden of coronary artery calcification on contrast-enhanced chest CT during clinical care.

Modality
CT/CTA
Anatomy
Chest/coronary arteries
Decision
2026-03-06
FDA-cleared K260167

Bunkerhill Contrast AVC

BunkerHill Health

Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.

Modality
CT/CTA
Anatomy
Chest/aortic valve
Decision
2026-03-06
FDA-cleared K251769

RevealAI-Lung

Precision Medical Ventures, Inc. Dba Revealdx

Characterization and relative cancer-risk assessment of incidentally detected pulmonary nodules 6-15 mm in adults, with use as one input to follow-up and clinical decision-making...

Modality
CT/CTA
Anatomy
Pulmonary nodules in the lungs
Decision
2026-01-30
FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...

Modality
X-ray/Radiography
Anatomy
Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
Decision
2026-01-16
FDA-cleared K252934

Diagnocat

DGNCT, LLC

Diagnocat is an automated concurrent-read aid for detecting periapical radiolucency on permanent teeth in previously acquired, clinically justified maxillofacial CBCT; it is a...

Modality
CBCT
Anatomy
Maxillofacial region; permanent teeth; periapical radiolucency
Decision
2026-01-15
FDA-cleared K253009

DS Core Detect

Dentsply Sirona, Inc.

Concurrent-read incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT data acquired for other reasons.

Modality
CBCT
Anatomy
Permanent teeth and periapical dental structures
Decision
2026-01-07
FDA-cleared K250959

BioticsAI

Bioticsai, Inc.

BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating...

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2025-12-22
FDA-cleared K250264

SugarBug (1.x)

Bench7, Inc.

Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-11-07
FDA-cleared K252007

BlineSlide

Deep Breathe, Inc.

Lung ultrasound cine processing for B-line artifact presence/absence detection.

Modality
Ultrasound
Anatomy
Chest/Lung
Decision
2025-10-06
FDA-cleared K251368

FETOLY

Diagnoly

FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...

Modality
Ultrasound
Anatomy
Fetal heart and fetal brain
Decision
2025-09-12
FDA-cleared K250753

VELMENI for DENTISTS (V4D)

Velmeni Inc.

Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-02
FDA-cleared K252362

GBrain MRI

Galileo CDS, Inc

Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.

Modality
MRI
Anatomy
Brain signal hyperintensities
Decision
2025-08-22
FDA-cleared K243341

Genius AI Detection 2.0

Hologic, Inc.

Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis exams to identify and mark soft-tissue densities (masses, architectural distortions, asymmetries) and...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2025-07-31
FDA-cleared K243884

TAVIPILOT

Caranx Medical

TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.

Modality
Fluoroscopy/Angiography
Anatomy
Heart/Cardiovascular
Decision
2025-07-07
FDA-cleared K243234

Second Opinion® CS

Pearl Inc.

Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-06-12
FDA-cleared K243667

Sonic DL

GE Medical Systems, LLC

Sonic DL is optional integrated GE MRI reconstruction for supported 2D cardiac cine and 3D fast-spin-echo or gradient-echo acquisitions at 1.5T, 3T, and 7T for all ages and...

Modality
MRI
Anatomy
Multi-region
Decision
2025-06-05
FDA-cleared K243810

TraumaCad Neo (1.1)

Brainlab Ltd.

TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip, knee, upper-limb, and foot orthopedic anatomy represented in X-ray or CT studies
Decision
2025-06-04
FDA-authorized DEN240047

Allix5

Clairity, Inc.

Allix5 generates a five-year breast-cancer-risk prediction from bilateral screening mammograms for eligible patients without known breast cancer at presentation; it is not...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2025-05-30
FDA-cleared K242437

Smile Dx®

Cube Click, Inc.

Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-05-14
FDA-cleared K243893

Second Opinion® Pediatric

Pearl, Inc.

Aids dental professionals in detecting caries on digital bitewing and periapical radiographs from patients aged 4 years and older with primary, permanent, or mixed dentition;...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-05-05
FDA-cleared K251071

Fetal EchoScan (v1.1)

BrightHeart

Adjunctive detection of suspicious fetal cardiac findings during second-trimester ultrasound to aid concurrent OB-GYN or maternal-fetal-medicine interpretation.

Modality
Ultrasound
Anatomy
Fetal heart, including four-chamber, left-ventricular-outflow-tract, and right-ventricular-outflow-tract views and the specified suspicious cardiac findings
Decision
2025-05-02
FDA-cleared K243239

Lung AI (LAI001)

Exo Inc

Lung AI LAI001 assists trained healthcare professionals performing point-of-care lung ultrasound by detecting and visualizing pleural effusion and consolidation or atelectasis in...

Modality
Ultrasound
Anatomy
Lung; pleural effusion and consolidation or atelectasis at the PLAPS point
Decision
2025-04-24
FDA-cleared K242600

Second Opinion Periapical Radiolucency Contours

Pearl Inc.

Second Opinion PC assists dentists by detecting and displaying periapical radiolucencies with bounding polygons on dental radiographs of permanent teeth in patients age 12 and...

Modality
X-ray/Radiography
Anatomy
Dental permanent teeth and periapical region
Decision
2025-04-11
FDA-cleared K250416

GBrain MRI

Galileo CDS, Inc

Post-processing automatic segmentation, quantification, and reporting of brain FLAIR hyperintensity volumes to support structural MRI review; not disease detection or diagnosis.

Modality
MRI
Anatomy
Adult brain, specifically T2-weighted FLAIR hyperintensities
Decision
2025-04-11
FDA-cleared K250754

cmAngio® (V1.6)

CureMetrix, Inc.

cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence...

Modality
Mammography/DBT
Anatomy
Female breasts; breast arterial calcification
Decision
2025-04-10
FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

QP-Prostate CAD detects and marks suspected prostate lesions for clinically significant prostate cancer on bi-parametric T2-weighted and diffusion-weighted prostate MRI, returning...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-18
FDA-cleared K241725

Better Diagnostics Caries Assist (BDCA) Version 1.0

Better Diagnostics AI Corp

Better Diagnostics Caries Assist is a concurrent-read computer-aided detection device that identifies and localizes carious lesions on bitewing and periapical radiographs of...

Modality
X-ray/Radiography
Anatomy
Dental permanent dentition and carious lesions
Decision
2025-03-11
FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-05
FDA-cleared K250035

Contour ProtégéAI+

MIM Software Inc.

Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive;...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomical regions; prostate, seminal vesicles, and urethra on T2 MR
Decision
2025-02-03
FDA-cleared K242171

TechCare Trauma

Milvue

Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle,...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2025-01-17
FDA-cleared K243538

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co.,Ltd.

The uMI Panvivo PET/CT system provides anatomical and functional images. PET depicts the distribution of approved radiopharmaceuticals and CT provides diagnostic tomographic and...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body and regional anatomy represented in PET/CT studies
Decision
2024-12-12
FDA-cleared K241747

Saige-Dx

DeepHealth, Inc

Concurrent reading aid for interpreting physicians on screening DBT mammograms to detect and characterize soft-tissue lesions and calcifications that may indicate cancer.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2024-11-18
FDA-cleared K242130

Koios DS

Koios Medical, Inc.

Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to...

Modality
Ultrasound
Anatomy
Breast
Decision
2024-11-15
FDA-cleared K242342

Fetal EchoScan

BrightHeart

Adjunctive CADx aid for interpreting OB-GYN/MFM physicians to identify suspicious fetal-cardiac findings in second-trimester anatomic ultrasound that may suggest congenital heart...

Modality
Ultrasound
Anatomy
Fetal heart, including the cardiac crux, outflow tracts, cardiac axis, ventricles, and valve annular relationships.
Decision
2024-11-14
FDA-cleared K240417

ProFound Detection (V4.0)

iCAD, Inc.

Concurrent CAD/CADx aid for interpreting physicians reading compatible DBT exams to detect soft-tissue densities and calcifications for physician confirmation or dismissal.

Modality
Mammography/DBT
Anatomy
Breast.
Decision
2024-11-08
FDA-cleared K240712

icobrain aria

icometrix NV

icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection,...

Modality
MRI
Anatomy
Brain
Decision
2024-11-07
FDA-cleared K240553

LVivo Software Application

DiA Imaging Analysis Ltd.

Non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function in patients with suspected disease, with...

Modality
Ultrasound
Anatomy
Heart and cardiovascular structures, especially the left and right ventricles; a bladder-volume module is also described
Decision
2024-10-04
FDA-cleared K242652

Lunit INSIGHT DBT v1.1

Lunit Inc.

Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2024-10-04
FDA-cleared K240942

CINA-CSpine

Avicenna.AI

Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...

Modality
CT/CTA
Anatomy
Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
Decision
2024-09-12
FDA-cleared K241380

FETOLY-HEART

Diagnoly

Concurrent AI reading aid for routine fetal heart ultrasound examinations in second- and third-trimester pregnancies from 17 to 40 weeks, detecting the five recommended fetal...

Modality
Ultrasound
Anatomy
Obstetric fetal heart
Decision
2024-09-11
FDA-cleared K240003

Velmeni for Dentists (V4D)

Velmeni Inc.

VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations,...

Modality
X-ray/Radiography
Anatomy
Permanent teeth; digital bitewing, periapical, and panoramic dental radiographs
Decision
2024-08-30
FDA-cleared K241684

Overjet Charting Assist

Overjet, Inc

Dental radiograph charting assistance for detecting natural and restorative dental structures and tooth numbering on bitewing, periapical, and panoramic images.

Modality
X-ray/Radiography
Anatomy
Dental/maxillofacial
Decision
2024-08-27
FDA-cleared K241596

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

The uMI Panvivo is a PET/CT system for anatomical and functional images. PET provides distribution information for approved radiopharmaceuticals and CT provides diagnostic...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body and regional anatomy represented in PET/CT studies
Decision
2024-08-15
FDA-cleared K240845

Rayvolve

AZmed SAS

Assists radiologists and emergency physicians in detecting fractures on DICOM musculoskeletal radiographs for adults and children aged 2 years or older, limited to the FDA-listed...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2024-07-17
FDA-cleared K233662

Radiography 7300 C

Philips Medical Systems DMC GmbH

Radiography 7300 C is a diagnostic radiography system for producing and processing projection X-ray images in the labeled clinical workflow; exact views, detectors, patient...

Modality
X-ray/Radiography
Anatomy
Multi-region
Decision
2024-06-13
FDA-cleared K240406

Sonio Detect

Sonio

Concurrent aid during acquisition and interpretation of fetal ultrasound examinations across gestational ages 11-37 weeks to detect supported views and structures and verify view...

Modality
Ultrasound
Anatomy
Fetus/obstetric anatomy, including fetal brain, heart/thorax, abdomen, placenta, and genitalia
Decision
2024-04-26
FDA-cleared K233342

CINA-ASPECTS

Avicenna.AI

CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and...

Modality
CT/CTA
Anatomy
Brain, including ASPECTS regions
Decision
2024-03-15
FDA-cleared K233738

Overjet Caries Assist-Pediatric

Overjet, Inc

Aid dentists in detecting and segmenting caries on bitewing and periapical radiographs for patients aged 4-11 with primary or permanent teeth; the output is additional information...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (carious tooth surfaces)
Decision
2024-03-04
FDA-cleared K233590

Overjet Charting Assist

Overjet, Inc

Assist dental professionals in producing dental charts by detecting tooth anatomy and numbering plus past restorative treatments on bitewing and periapical images for patients...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (tooth anatomy, numbering, and restorative structures)
Decision
2024-02-23
FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

The Biograph VK10 combines X-ray CT and PET to register and fuse anatomic and physiologic information, supports independent CT or PET imaging, and aids trained professionals in...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
Decision
2024-01-12
FDA-cleared K231805

qXR-LN

Qure.ai Technologies

Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population

Modality
X-ray/Radiography
Anatomy
Chest/lung, focused on suspected pulmonary nodules
Decision
2023-12-22
FDA-cleared K231898

DTX Studio Clinic (4.0)

Nobel Biocare AB

Acquire, manage, transfer, analyze, display, enhance, store, and communicate dental and craniomaxillofacial image information for diagnosis and treatment planning, restorative...

Modality
X-ray/Radiography
Anatomy
Dental and craniomaxillofacial regions; permanent teeth
Decision
2023-12-08
FDA-cleared K231470

Lunit INSIGHT DBT

Lunit Inc.

Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2023-11-06
FDA-cleared K230220

NeuViz 128 Multi-Slice CT Scanner System

Neusoft Medical Systems Co., Ltd.

The NeuViz 128 Multi-Slice CT Scanner System is a whole-body computed-tomography X-ray system with a continuously rotating X-ray tube and detector array that reconstructs X-ray...

Modality
CT/CTA
Anatomy
Whole body including head
Decision
2023-10-11
FDA-cleared K230144

Denti.AI Detect

Denti.AI Technology, Inc.

Second-reader CADe support for detecting/highlighting caries and periapical radiolucency and for measuring mesial and distal bone levels on extraoral and intraoral 2D dental...

Modality
X-ray/Radiography
Anatomy
Teeth and dental/maxillofacial structures
Decision
2023-10-06
FDA-cleared K231001

DeepTek CXR Analyzer v1.0

DeepTek Medical Imaging Pvt Ltd

Concurrent CADe support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs...

Modality
X-ray/Radiography
Anatomy
Chest: lungs, pleura, cardiac structures, and hardware
Decision
2023-10-05
FDA-cleared K232367

cmAngio® V1.0

CureMetrix, Inc.

cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified...

Modality
Mammography/DBT
Anatomy
Breast; breast arterial calcifications
Decision
2023-10-05
FDA-cleared K230085

Lung-CAD

Imagen Technologies, Inc

Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for lung hyperinflation. The device uses a deep learning algorithm to...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-10-03
FDA-cleared K232712

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-10-03
FDA-cleared K231678

Overjet Periapical Radiolucency Assist

Overjet, Inc

Overjet Periapical Radiolucency Assist is a concurrent-read aid for detecting periapical radiolucencies on periapical radiographs of permanent teeth in patients aged 12 years and...

Modality
X-ray/Radiography
Anatomy
Permanent teeth; periapical regions
Decision
2023-09-21
FDA-cleared K223811

Lung-CAD

Imagen Technologies, Inc

Lung-CAD is a concurrent-read computer-aided detection aid for identifying and marking regions of interstitial thickening on adult chest radiographs; it does not provide a...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-09-13
FDA-cleared K223133

VisiRad XR

Imidex Inc.

VisiRad XR is a computer-aided detection device that identifies and marks regions of interest suspicious for lung nodules and masses measuring 6-60 mm on chest radiographs in...

Modality
X-ray/Radiography
Anatomy
Adult chest and pulmonary nodules or masses 6-60 mm
Decision
2023-08-03
FDA-cleared K231572

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-07-26
FDA-cleared K230365

Sonio Detect

Sonio

Analyze fetal ultrasound images and clips to automatically detect views, detect anatomical structures within views, and verify view-quality criteria as a concurrent reading aid...

Modality
Ultrasound
Anatomy
Fetus and fetal anatomy
Decision
2023-07-25
FDA-cleared K231833

Biograph Vision.X and Biograph Vision.X Edge

Siemens Medical Solutions USA, Inc.

The Biograph Vision.X and Biograph Vision.X Edge combine X-ray CT and PET to register and fuse anatomic and physiologic information, support independent CT or PET imaging, aid...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
Decision
2023-07-13
FDA-cleared K222746

Overjet Caries Assist

Overjet, Inc.

Concurrent-read CADe to aid professionally trained and licensed dentists in detecting and segmenting caries on bitewing and periapical radiographs; the output is additional...

Modality
X-ray/Radiography
Anatomy
Permanent dentition and tooth surfaces in dental/maxillofacial anatomy
Decision
2023-03-27
FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-03-17
FDA-cleared K223325

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-03-10
FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
FDA-cleared K222970

LVivo IQS

DiA Imaging Analysis Ltd

Non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters of structures and function in patients with suspected disease, with Quality Score...

Modality
Ultrasound
Anatomy
Heart; left ventricle from the four-chamber apical view
Decision
2023-02-01
FDA-cleared K220928

Overjet Calculus Assist

Overjet Inc.

Concurrent-read CADe to aid professionally trained and licensed dentists in detecting interproximal calculus deposits on bitewing and periapical radiographs; the output is...

Modality
X-ray/Radiography
Anatomy
Interproximal tooth surfaces in dental/maxillofacial anatomy
Decision
2022-12-16
FDA-cleared K222428

Syngo Dynamics (Version VA40F)

Siemens Medical Solutions USA, Inc.

Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in multimodality cardiology medical images, excluding U.S. digital mammography diagnosis
Decision
2022-11-14
FDA-cleared K221305

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc

AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-10-14
FDA-cleared K221449

Genius AI Detection 2.0

Hologic, Inc.

Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case...

Modality
Mammography/DBT
Anatomy
Breast; soft-tissue densities, architectural distortions or asymmetries, and calcifications
Decision
2022-10-06
FDA-cleared K211611

QIR Suite

CASIS Cardiac Simulation & Imaging Software

QIR Suite is intended to be used for viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM (Digital Imaging and...

Modality
MRI
Anatomy
Heart/Cardiovascular
Decision
2022-09-30
FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2022-09-28
FDA-cleared K213353

Aorta-CAD

Imagen Technologies, Inc

Concurrent-read CADe to aid physicians in detecting and localizing chest-radiograph ROIs labeled aortic calcification or dilated aorta, suggestive of aortic atherosclerosis or...

Modality
X-ray/Radiography
Anatomy
Aorta and thoracic aortic findings on chest radiographs
Decision
2022-09-20
FDA-cleared K212783

ProstatID

ScanMed, LLC

Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or...

Modality
MRI
Anatomy
Prostate
Decision
2022-07-08
FDA-cleared K221463

ElucidVivo A.3

Elucid Bioimaging Inc.

ElucidVivo A.3 postprocesses contrast multidetector CT to visualize arterial vessels and provide semi-automatic lumen boundaries, stenosis and lumen measurements, vessel length,...

Modality
CT/CTA
Anatomy
Arterial vessels and atherosclerotic disease
Decision
2022-06-17
FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and...

Modality
CT/CTA
Anatomy
Brain/Cerebrovascular
Decision
2022-06-03
FDA-cleared K220164

Rayvolve

AZmed SAS

Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for...

Modality
X-ray/Radiography
Anatomy
Musculoskeletal system: ankle, clavicle, elbow, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, wrist, hand, and foot
Decision
2022-06-02
FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...

Modality
MRI
Anatomy
Multi-region
Decision
2022-05-13
FDA-cleared K212519

Overjet Caries Assist

Overjet, Inc.

Overjet Caries Assist is a concurrent-read aid for detecting and segmenting caries on bitewing radiographs of permanent dentition in patients aged 18 years and older; it provides...

Modality
X-ray/Radiography
Anatomy
Permanent dentition; tooth surfaces and caries
Decision
2022-05-10
FDA-cleared K212915

MVision AI Segmentation

MVision AI

MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review,...

Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, brain, breast, lung and abdomen, male pelvis, and female pelvis structures
Decision
2022-05-03
FDA-cleared K213795

Videa Caries Assist

VideaHealth, Inc

Concurrent-read CADe to identify and localize carious lesions on bitewing radiographs from adults at least 22 years old for board-licensed dentists; the device is an aid and does...

Modality
X-ray/Radiography
Anatomy
Teeth and tooth surfaces, including proximal, buccal/lingual, occlusal, root, and cervical surfaces
Decision
2022-04-21
FDA-cleared K213319

Viz ANEURYSM, Viz ANX

Viz.ai, Inc.

Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Head
Decision
2022-02-18
FDA-cleared K213976

Contour ProtégéAI

MIM Software Inc.

Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
Decision
2022-02-03
FDA-cleared K210760

Precise Image

Philips Medical Systems Nederland, B.V.

Precise Image is an adult head-and-body CT reconstruction application for selected Philips Incisive CT protocols that uses a convolutional neural network to reduce noise and...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2022-01-14
FDA-cleared K212616

Koios DS

Koios Medical, Inc.

Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound...

Modality
Ultrasound
Anatomy
Breast
Decision
2021-12-16
FDA-cleared K211678

Lunit INSIGHT MMG

Lunit Inc.

Aid interpreting physicians in detecting, localizing, and characterizing suspicious breast-cancer areas on mammograms from compatible FFDM systems, viewed after the physician...

Modality
Mammography/DBT
Anatomy
Breast.
Decision
2021-11-17
FDA-cleared K210085

HealthCCSng

Zebra Medical Vision Ltd.

The HealthCCSng is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2021-09-15
FDA-cleared K201560

Auto Lung Nodule Detection

Samsung Electronics Co.,Ltd.

The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-08-31
FDA-cleared K212383

EndoNaut

Therenva SAS

EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm,...

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2021-08-31
FDA-cleared K211764

Vereos PET/CT

Philips Medical Systems Nederland B.V.

Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2021-08-06
FDA-cleared K210666

Chest-CAD

Imagen Technologies, Inc

Concurrent CADe reading aid that identifies, categorizes, and highlights suspicious regions of interest on adult chest radiographs

Modality
X-ray/Radiography
Anatomy
Chest/thorax, with ROI categories covering cardiac, mediastinum/hila, lungs, pleura, bones, soft tissues, hardware, and other
Decision
2021-07-20
FDA-cleared K210237

CINA CHEST

Avicenna.AI

Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital...

Modality
CT/CTA
Anatomy
Chest and thoraco-abdominal aorta
Decision
2021-05-19
FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is...

Modality
CT/CTA
Anatomy
Pulmonary nodules in the thorax, including solid and subsolid (part-solid and ground-glass) nodules.
Decision
2021-03-31
FDA-cleared K203822

ProFound AI Software V3.0

iCAD Inc.

Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions,...

Modality
Mammography/DBT
Anatomy
Breast, including soft-tissue densities and calcifications in 3D DBT slices.
Decision
2021-03-12
FDA-cleared K201019

Genius AI Detection

Hologic, Inc.

Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring...

Modality
Mammography/DBT
Anatomy
Breast; soft-tissue densities and calcifications in digital breast tomosynthesis
Decision
2020-11-18
FDA-cleared K193562

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Organs RT VA20 automatically contours predefined organs at risk from adult DICOM CT for qualified review, editing, and DICOM RTSTRUCT transfer into...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-11-06
FDA-cleared K202280

Cleerly Labs v2.0

Cleerly, Inc.

Web-based post-processing of cardiac CT data from CCTA performed for CAD or suspected CAD to view and analyze coronary plaques/atherosclerosis and stenosis and support measurement...

Modality
CT/CTA
Anatomy
Heart; coronary arteries, plaques, and stenosis
Decision
2020-10-02
FDA-cleared K202546

LVivo Seamless

DiA Imaging Analysis Ltd

LVivo Seamless non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with...

Modality
Ultrasound
Anatomy
Structures and function represented in supported ultrasound examinations
Decision
2020-09-29
FDA-cleared K193417

FractureDetect (FX)

Imagen Technologies, Inc.

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2020-07-30
FDA-cleared K193073

Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Deep Recon is a data-driven deep-learning CT reconstruction method for axial, helical, and cardiac acquisitions. It is designed to generate lower-noise CT images, improve...

Modality
CT/CTA
Anatomy
Adult head, chest, abdomen, cardiac, and vascular CT
Decision
2020-07-06
FDA-cleared K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

Computer-assisted reading aid for radiologists detecting pulmonary nodules during review of chest CT examinations in an asymptomatic population; both lungs must be in the field of...

Modality
CT/CTA
Anatomy
Chest; pulmonary nodules in both lungs
Decision
2020-07-02
FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Abdomen
Decision
2020-06-19
FDA-cleared K193216

syngo.CT Lung CAD

Siemens Medical Solutions, Inc

Adjunctive CAD assistance to alert radiologists to potentially overlooked solid pulmonary nodules during chest MDCT review; second-reader use only after the radiologist's initial...

Modality
CT/CTA
Anatomy
Solid pulmonary nodules in the thorax.
Decision
2020-03-09
FDA-cleared K191994

ProFound AI Software V2.1

iCAD Inc.

ProFound AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-10-04
FDA-cleared K183133

MRCP+ v1.0

Perspectum Diagnostics Ltd

MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation,...

Modality
MRI
Anatomy
Abdomen
Decision
2019-01-09
FDA-cleared K183012

vascuCAP

Elucid Bioimaging Inc.

vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2018-12-21
FDA-cleared K182373

PowerLook Tomo Detection V2 Software

iCAD Inc.

PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2018-12-06
FDA-cleared K181572

Workflow Box

Mirada Medical Ltd.

Workflow Box is a software system for routing DICOM-compliant data to and from automated processing components. It supports atlas-based contouring, deformable-image-registration...

Modality
Radiotherapy Planning Imaging
Anatomy
CT, MR, and RTSTRUCT imaging data for automated contours and radiotherapy planning
Decision
2018-07-10
FDA-authorized DEN180005

OsteoDetect

Imagen Technologies, Inc.

Computer-aided detection and localization of distal radius fractures on adult wrist PA/LAT radiographs as an adjunct to clinician review.

Modality
X-ray/Radiography
Anatomy
Adult wrist, specifically the distal radius
Decision
2018-05-24
FDA-cleared K170069

AmCAD-UV

AmCad BioMed Corporation

AmCAD-UV classifies ultrasonic color-intensity data and lets users view primary pulsatile, secondary pulsatile, and unidentified signals in flow-Doppler ultrasound images. It is a...

Modality
Ultrasound
Anatomy
Vascular structures; pulsatile flow signals
Decision
2017-04-26
FDA-approved P160009

PowerLook® Tomo Detection Software

iCAD Inc

Concurrent computer-aided detection for radiologists interpreting compatible GE Senoclaire breast tomosynthesis examinations, with detected soft-tissue densities blended into the...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2017-03-24
FDA-cleared K161959

ClearView cCAD

ClearView Diagnostics Inc.

ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation...

Modality
Ultrasound
Anatomy
Breast
Decision
2016-12-28
FDA-approved P150043

QVCAD System

QView Medical, Inc.

The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System,...

Modality
Ultrasound
Anatomy
Female breasts; mammography-occult lesions in non-suspicious regions
Decision
2016-11-09
FDA-cleared K161201

ClearRead CT

RIVERAIN TECHNOLOGIES, LLC

ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe...

Modality
CT/CTA
Anatomy
Chest/lungs
Decision
2016-09-09
FDA-approved P010034

SECOND LOOK ™

ICAD, INC.

The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has...

Modality
Mammography/DBT
Anatomy
Breast / standard mammographic views
Decision
2002-01-31
FDA-approved P000041

RAPIDSCREEN RS-2000

RIVERAIN MEDICAL GROUP

RAPIDSCREEN RS-2000 is a PMA-authorized computer-aided detection device that identifies and marks regions of interest on digitized frontal chest radiographs associated with...

Modality
X-ray/Radiography
Anatomy
Adult chest; solitary pulmonary nodules 9-30 mm
Decision
2001-07-12
FDA-approved P980025

LOGICON CARIES DETECTOR

CARESTREAM DENTAL LLC

LOGICON Caries Detector is adjunct software for detecting caries extending into dentin on unrestored proximal surfaces of secondary dentition in supported digital intraoral...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
1998-09-02