FDA-cleared K253192

DeepXray Spina

Alpha Intelligence Manifolds, Inc.

Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a...

Modality
X-ray/Radiography
Anatomy
Spine/Bone Health
Decision
2026-06-10
FDA-cleared K254120

SubtleHD-CT (1.x)

Subtle Medical, Inc.

Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.

Modality
CT/CTA
Anatomy
Multiple CT anatomies: abdomen, C-spine, cardiac, chest, chest-abdomen-pelvis, head, head/neck, L-spine, lower extremity, MSK, T-spine, and upper extremity.
Decision
2026-05-15
FDA-cleared K261289

UNiD™ Spine Analyzer (SW3002)

Medicrea International S.A.S. (Medtronic)

UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine
Decision
2026-05-15
FDA-cleared K260378

Rayvolve

AZmed

Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.

Modality
X-ray/Radiography
Anatomy
Musculoskeletal and chest/ribs radiographs across specified views
Decision
2026-05-12
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 K254015

CoLumbo C-Spine

Smart Soft Healthcare AD

Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for...

Modality
MRI
Anatomy
Cervical spine: vertebrae C3-C7 and disks C2C3 through C7T1
Decision
2026-04-01
FDA-cleared K253686

True Definition DL

Ge Healthcare Japan Corporation

True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.

Modality
CT/CTA
Anatomy
Bone and lungs
Decision
2026-03-23
FDA-cleared K251901

Magnifico Open (100009900)

Esaote, S.p.A.

Magnifico Open is a general-purpose MRI system that acquires, displays, and analyzes MR images and real-time imaging for the labeled body regions and open-MRI applications.

Modality
MRI
Anatomy
Calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, spine, pelvis, temporomandibular joint, head, and upper abdomen
Decision
2026-03-05
FDA-cleared K253578

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical, Ltd.

BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...

Modality
CT/CTA
Anatomy
Chest and abdomen; pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture/dislocation
Decision
2026-02-26
FDA-cleared K253780

SIGNA™ Bolt

Ge Medical Systems, LLC

SIGNA Bolt is a whole-body MRI system for high-resolution diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol...

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and musculoskeletal anatomy
Decision
2026-02-06
FDA-cleared K253779

SIGNA™ Sprint Select

Ge Medical Systems, LLC

SIGNA Sprint Select is a whole-body MRI system for diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol functions.

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and musculoskeletal anatomy
Decision
2026-02-05
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 K252029

AI-CVD

HeartLung Corporation

AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...

Modality
CT/CTA
Anatomy
Chest, abdomen, heart, lungs, liver, aorta, pulmonary artery, bone, muscle, and fat
Decision
2025-12-19
FDA-cleared K250914

MediAI-BA

Crescom Co., Ltd.

View and quantify bone age from 2D posteroanterior left-hand radiographs to aid pediatric radiologists assessing patients aged 2-18 years.

Modality
X-ray/Radiography
Anatomy
Left hand and wrist; skeletal maturity/bone age
Decision
2025-12-18
FDA-cleared K252086

DTX Studio Assist

Nobel Biocare C/O Medicim NV

Analyzes two-dimensional bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize caries, calculus, periapical radiolucency,...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-11-17
FDA-cleared K251078

AutoDensity

Eos Imaging

AutoDensity estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment; it is not a replacement for...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-11-14
FDA-cleared K251059

Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole spine and other clinical image regions represented in supported CT and MR workflows
Decision
2025-10-24
FDA-cleared K252214

AIAS Cephalon

Metamorphosis GmbH

AIAS Cephalon assists qualified healthcare professionals during adult proximal femur fracture surgery by measuring and positioning implant components relative to bone structures...

Modality
Fluoroscopy/Angiography
Anatomy
Femur/hip
Decision
2025-10-07
FDA-cleared K251167

uDR Aurora CX

Shanghai United Imaging Healthcare Co., Ltd.

uDR Aurora CX acquires two-dimensional X-ray images of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk for review by qualified healthcare professionals; it...

Modality
X-ray/Radiography
Anatomy
Skull, spine, chest, abdomen, extremities, limbs, and trunk
Decision
2025-09-19
FDA-cleared K251399

SIGNA™ Sprint

GE Medical Systems, LLC

SIGNA Sprint is a 1.5T whole-body MRI system for diagnostic imaging of the labeled head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and...

Modality
MRI
Anatomy
Head; neck; temporomandibular joint; spine; breast; heart; abdomen; pelvis; joints; prostate; vessels; and musculoskeletal anatomy
Decision
2025-09-11
FDA-cleared K251682

MuscleView 2.0

Springbok, Inc. (dba Springbok Analytics)

Automatic MRI segmentation and quantitative analysis of muscle, bone, fat, and other anatomical structures to assist visualization and measurement; not direct disease diagnosis.

Modality
MRI
Anatomy
Muscles, bones, and adipose tissue across the lower extremities and upper body from neck to hips, plus other segmented structures
Decision
2025-09-09
FDA-cleared K251408

OsteoSight™ Hip (v1)

Naitive Technologies Ltd

Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2025-09-02
FDA-cleared K250788

Definium Tempo Select

GE Hualun Medical Systems Co., Ltd

Definium Tempo Select acquires, displays, and manages digital radiographic images of the skull, spine, chest, abdomen, extremities, and other labeled body parts for routine...

Modality
X-ray/Radiography
Anatomy
Skull; spinal column; chest; abdomen; extremities; and other routine radiography anatomy
Decision
2025-08-28
FDA-cleared K251747

VEA Align; spineEOS

EOS imaging

VEA Align is cloud-based software for orthopedic applications in adult and pediatric populations using two-dimensional X-ray images from EOS imaging systems to display interactive...

Modality
X-ray/Radiography
Anatomy
Spine and lower-limb alignment; frontal and lateral EOS images and associated 3D datasets
Decision
2025-08-15
FDA-cleared K251629

UNiD™ Spine Analyzer

Medicrea International S.A.S. (Medtronic)

UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements,...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine
Decision
2025-08-07
FDA-cleared K243647

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2025-06-30
FDA-cleared K250367

CoLumboX

Smart Soft Healthcare AD

Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.

Modality
X-ray/Radiography
Anatomy
Lumbar spine, including vertebrae and sacrum
Decision
2025-05-28
FDA-cleared K243937

Accuro 3S

Rivanna Medical, Inc.

Accuro 3S is portable B-mode ultrasound with SpineNav-AI for lumbar-spine scouting and epidural-depth estimation during neuraxial-anesthesia and needle or catheter placement...

Modality
Ultrasound
Anatomy
Spine
Decision
2025-05-23
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 K242624

Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...

Modality
CT/CTA
Anatomy
Colon, lungs and airway, vessels, brain, heart, liver, ribs, spine, and other CT regions
Decision
2025-05-14
FDA-cleared K243230

Second Opinion® BLE

Pearl Inc.

Second Opinion BLE identifies and displays bone-level measurements in bitewing and periapical radiographs for dental health professionals reviewing permanent teeth in patients age...

Modality
X-ray/Radiography
Anatomy
Dental permanent teeth and alveolar bone
Decision
2025-05-09
FDA-cleared K242295

BunkerHill BMD

BunkerHill Health

Analyzes existing CT images in DICOM format from adults aged 30 years and older to estimate average areal BMD of spinal bones and flag low bone density below a preset threshold,...

Modality
CT/CTA
Anatomy
Spine
Decision
2025-04-08
FDA-cleared K250379

SIGNA Prime Elite

GE Medical Systems, LLC

SIGNA Prime Elite is a whole-body MR system that produces cross-sectional, spectroscopic, parametric, and dynamic images of the labeled body regions for trained physician...

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and musculoskeletal anatomy
Decision
2025-03-17
FDA-cleared K241593

BoneMetrics (US)

Gleamer SAS

BoneMetrics is fully automated software that assists trained radiology professionals with Cobb-angle measurement on frontal spine radiographs in patients aged four years or older...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-02-05
FDA-cleared K243350

Rapid Neuro3D

iSchemaView, Inc.

Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations,...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-22
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 K241350

Clarify DL

GE Medical Systems Israel, Functional Imaging

Clarify DL is a deep-learning reconstruction function intended to reduce noise and improve image quality of nuclear-medicine bone SPECT scintigraphy for all ages on the supported...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2025-01-03
FDA-cleared K241696

Ortho AI

Ortho AI LLC

Ortho AI measures lengths, angles, and implant position relative to bone on radiographic images for total hip arthroplasty, total knee arthroplasty, and lumbar-spine fusion...

Modality
X-ray/Radiography
Anatomy
Pelvis, knee, and lumbar spine
Decision
2025-01-02
FDA-cleared K240793

MSKai

MSKai

Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is...

Modality
MRI
Anatomy
Lumbar spine, including vertebral bodies L1-S1, intervertebral discs, cord canal, dural sac, nerve roots, and posterior arch.
Decision
2024-12-16
FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.

Modality
CT/CTA
Anatomy
Ribs
Decision
2024-12-11
FDA-cleared K241242

SIGNA MAGNUS

GE Medical Systems, LLC

SIGNA MAGNUS is a head-only MR system intended for diagnostic imaging of structures and functions of the head, neck, temporomandibular joint, and limited cervical spine in...

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, and limited cervical spine
Decision
2024-10-17
FDA-cleared K241331

MuscleView

Springbok, Inc.

Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat...

Modality
MRI
Anatomy
Lower extremities; 72 muscles and 8 bones including pelvis, femur, tibia, and fibula, bilaterally
Decision
2024-10-01
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 K241211

CoLumbo

Smart Soft Healthcare

CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.

Modality
MRI
Anatomy
Lumbar spine
Decision
2024-08-15
FDA-cleared K241665

Omni Legend

GE Medical Systems Israel, Functional Imaging

Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone,...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2024-08-08
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 K241329

SubtleSYNTH (1.x)

Subtle Medical, Inc.

SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.

Modality
MRI
Anatomy
Spine
Decision
2024-07-11
FDA-cleared K240582

VEA Align; spineEOS

EOS imaging

VEA Align uses 2D X-ray images acquired in EOS imaging systems to display interactive landmarks and support global-alignment assessment, angle and length measurements, and...

Modality
X-ray/Radiography
Anatomy
Spine and lower limbs; global alignment and deformity
Decision
2024-06-25
FDA-cleared K240465

O-arm O2 Imaging System

Medtronic Navigation, Inc

O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact...

Modality
CBCT
Anatomy
Spine
Decision
2024-06-21
FDA-cleared K234042

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

Ever Fortune.AI Co., Ltd.

Aid pediatric radiologists in assessing bone age from PA left-hand radiographs for patients aged 2-16 years; the result is an adjunct and must not be used alone for diagnostic...

Modality
X-ray/Radiography
Anatomy
Left hand and wrist / skeletal age
Decision
2024-06-07
FDA-cleared K240612

CINA-VCF

Avicenna.AI

Parallel worklist triage for suspected vertebral compression fractures in patients aged 50 years and over within the standard-of-care bone-health setting; not a diagnostic device

Modality
CT/CTA
Anatomy
Thoracic and lumbar vertebrae T1-L5 within chest and/or abdomen CT
Decision
2024-05-31
FDA-cleared K233543

YSIO X.pree

Siemens Medical Solutions

YSIO X.pree is a digital X-ray system designed to visualize anatomical structures and generate X-ray images from the whole body, including the skull, chest, abdomen, spine, limbs,...

Modality
X-ray/Radiography
Anatomy
Skull, chest, abdomen, spine, extremities, limbs, and trunk
Decision
2024-05-21
FDA-cleared K233209

uOmnispace.CT

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...

Modality
CT/CTA
Anatomy
Colon, jaw, lungs, airways, brain, heart, vessels, liver, spine, ribs, and other labeled CT regions
Decision
2024-05-17
FDA-authorized DEN230023

Rho

16 Bit Inc

Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health...

Modality
X-ray/Radiography
Anatomy
Lumbar spine, thoracic spine, chest, pelvis, knee, hand, and wrist; low bone-mineral-density screening regions
Decision
2024-04-09
FDA-cleared K233030

BoneMRI

MRIguidance B.V

MRI-based BoneMRI image enhancement for visualizing pelvic and cervical, thoracic, lumbar and S1 spinal bone structures with CT-like radiodensity contrast; not for tumor diagnosis...

Modality
MRI
Anatomy
Spine
Decision
2024-03-01
FDA-cleared K233728

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra,...

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body
Decision
2024-01-19
FDA-cleared K231917

VEA Align

EOS imaging

VEA Align is cloud-based orthopedic software that uses 2D frontal and lateral X-ray images acquired in EOS imaging systems to display interactive landmarks and support...

Modality
X-ray/Radiography
Anatomy
Spine and lower-limb alignment anatomy
Decision
2024-01-05
FDA-cleared K223757

Bonelogic

Disior Ltd

Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...

Modality
CT/CTA
Anatomy
Foot/ankle
Decision
2023-12-08
FDA-cleared K232440

Adravision Perio

Adra Corporation

Adravision Perio is semi-automated radiological image-processing software intended to aid dental professionals in measuring mesial and distal bone levels associated with each...

Modality
X-ray/Radiography
Anatomy
Teeth and mesial or distal alveolar bone levels
Decision
2023-12-05
FDA-cleared K231955

aprevo® Digital Segmentation

Carlsmed, Inc.

aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine, primarily lumbar anatomy
Decision
2023-11-03
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 K232023

Momentum Spine

Momentum Health Inc.

The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including...

Modality
Optical Surface Imaging
Anatomy
Torso and spine; postural asymmetry and scoliosis
Decision
2023-10-04
FDA-cleared K231757

Ez3D-i /E3

Ewoosoft Co., Ltd

Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2023-07-14
FDA-cleared K223424

Spine Auto Views

GE Medical Systems SCS

Use with CT images to automatically generate anatomically focused multi-planar spine reformats, apply vertebral-body and intervertebral-disc labels, and export the results to...

Modality
CT/CTA
Anatomy
Spine
Decision
2023-07-13
FDA-cleared K223426

ECHELON Synergy MRI system

FUJIFILM Healthcare Corporation

The ECHELON Synergy MRI system is a 1.5T MR imaging device that provides non-ionizing physiological and clinical information and produces transverse, coronal, sagittal, oblique,...

Modality
MRI
Anatomy
Head, spine, cardiac, breast, abdomen, pelvis, shoulder, wrist, knee, ankle, and other labeled whole-body regions
Decision
2023-07-13
FDA-cleared K231668

Spine CAMP™ (1.1)

Medical Metrics, Inc.

Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration...

Modality
X-ray/Radiography
Anatomy
Spine, including sagittal lumbar and cervical spine; femoral-head landmarks for spinopelvic measurements
Decision
2023-07-07
FDA-cleared K223556

DeepCatch

MEDICALIP Co., Ltd

DeepCatch analyzes whole-body CT images to segment skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and central nervous system structures, then calculates...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2023-06-16
FDA-cleared K223623

SubtleMR (2.3.x)

Subtle Medical Inc.

MRI image enhancement by reducing image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increasing image sharpness for head MRI.

Modality
MRI
Anatomy
Head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions
Decision
2023-05-11
FDA-cleared K221921

DTX Studio Clinic 3.0

Nobel Biocare AB

DTX Studio Clinic 3.0 analyzes intraoral bitewing and periapical radiographs of permanent teeth in patients aged 15 years and older to identify and localize caries, calculus,...

Modality
X-ray/Radiography
Anatomy
Permanent teeth; intraoral dental findings
Decision
2023-03-28
FDA-cleared K222174

RadioLens v1.0

Synapsica

RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine, including cervical and lumbar vertebrae; general DICOM images excluding mammography
Decision
2023-03-28
FDA-cleared K223514

Spectral Bone Marrow

GE Medical Systems, LLC

Spectral Bone Marrow is an automated image processing software application, utilizing deep learning technology for bone segmentation, to facilitate optimized visualization of bone...

Modality
CT/CTA
Anatomy
Whole Body
Decision
2023-03-09
FDA-cleared K222176

BoneView

Gleamer

BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs,...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2023-03-02
FDA-cleared K221680

Xeleris V Processing and Review System

GE Healthcare

The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, lung, brain, liver, cardiac, coronary, and other anatomy represented in labeled nuclear-medicine studies
Decision
2023-03-01
FDA-cleared K230197

BoneMRI v1.6

MRIguidance B.V.

MRI-based BoneMRI v1.6 image enhancement for visualizing pelvic and L3-S1 lumbar bone structures with enhanced contrast; not for tumor diagnosis or monitoring and not a CT...

Modality
MRI
Anatomy
Spine
Decision
2023-02-22
FDA-cleared K223439

SIGNA Victor

GE Healthcare (Tianjin) Company Limited

SIGNA Victor is a whole-body magnetic-resonance scanner for high-resolution imaging, high signal-to-noise ratio, and short scan times. It is indicated to produce axial, sagittal,...

Modality
MRI
Anatomy
Entire body including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions
Decision
2023-02-13
FDA-cleared K223296

Videa Perio Assist

VideaHealth, Inc.

Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2023-02-06
FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

Chest CT (with or without contrast) triage and notification for suspected three or more acute rib fractures in adults or transitional adolescents age 18 or older; notifications...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-01
FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-12-05
FDA-cleared K221762

BoneMRI v1.4

MRlguidance B.V.

BoneMRI enhances bone contrast in dedicated MRI examinations of the pelvic sacrum, hip bones, femoral heads, and lumbar spine from L3 through S1; it is not intended to diagnose or...

Modality
MRI
Anatomy
Pelvic sacrum, hip bones, femoral heads, and lumbar spine L3-S1
Decision
2022-11-16
FDA-cleared K221632

Spine CAMP™

Medical Metrics, Inc.

Spine CMAP is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP can be used to obtain...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-10-18
FDA-cleared K221432

Customize

3D-Side SA

Customize supports adult total ankle arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, treatment-plan review, and...

Modality
CT/CTA
Anatomy
Foot/Ankle
Decision
2022-08-03
FDA-cleared K213760

ABMD Software

HeartLung Corporation

The Automated Bone Mineral Density Software Module measures bone mineral density from existing CT by averaging Hounsfield units in trabecular vertebral bone and can calculate age-...

Modality
CT/CTA
Anatomy
Trabecular vertebral bone and lumbar spine
Decision
2022-07-29
FDA-cleared K220497

CoLumbo

Smart Soft Healthcare AD

CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR)...

Modality
MRI
Anatomy
Spine
Decision
2022-06-23
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 K213944

HealthOST

NanoxAI Ltd.

Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss...

Modality
CT/CTA
Anatomy
Spine, including T1-L4 vertebrae and T11-L4 trabecular bone regions
Decision
2022-04-22
FDA-cleared K213779

Customize

3D-Side SA

Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it...

Modality
CT/CTA
Anatomy
Shoulder
Decision
2022-03-16
FDA-cleared K212365

BoneView

Gleamer

BoneView is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.

Modality
X-ray/Radiography
Anatomy
Ankle, foot, knee, tibia/fibula, femur, wrist, hand, elbow, forearm, humerus, shoulder, clavicle, pelvis, hip, ribs, thoracic spine, and lumbosacral spine
Decision
2022-03-01
FDA-cleared K212005

UNiD Spine Analyzer

MEDICREA International, Inc.

The UNiDTM Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-01-12
FDA-cleared K202404

BoneMRI

MRIguidance B.V

BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and...

Modality
MRI
Anatomy
Pelvic sacrum, hip bones, and femoral heads
Decision
2021-12-22
FDA-cleared K211828

Aquilion Exceed LB

Canon Medical Systems Corporation

Aquilion Exceed LB is a CT system for cross-sectional imaging of the labeled body regions and examinations described in K211828, with professional review of acquired and...

Modality
CT/CTA
Anatomy
Head, neck, chest, abdomen, pelvis, spine, extremities, and other CT anatomy
Decision
2021-09-10
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 K210187

Overjet Dental Assist

Overjet, Inc.

Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2021-05-19
FDA-cleared K203182

SubtleMR

Subtle Medical, Inc.

SubtleMR is MRI image-processing software for reducing noise in supported head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI or increasing sharpness for...

Modality
MRI
Anatomy
Multi-region
Decision
2021-02-26
FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-01-15
FDA-cleared K203508

BriefCase

Aidoc Medical, Ltd.

BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...

Modality
CT/CTA
Anatomy
Adult head, brain, cervical spine, pulmonary arteries, and thorax
Decision
2020-12-29
FDA-cleared K202487

HealthJOINT

Zebra Medical Vision Ltd.

The Zebra HealthJOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2020-12-04
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 K200921

qER

Qure.ai Technologies

qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-06-17
FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral...

Modality
CT/CTA
Anatomy
Vertebral bodies and spine as seen on chest and abdominal CT; suspected vertebral compression fractures
Decision
2020-05-12
FDA-cleared K192279

PhantomMSK Trauma

OrthoGrid Systems Inc.

PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning...

Modality
X-ray/Radiography
Anatomy
Whole Body
Decision
2019-12-07
FDA-cleared K191262

aBSI

EXINI Diagnostics AB

aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2019-08-05
FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

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

Modality
CT/CTA
Anatomy
Spine
Decision
2019-05-31
FDA-cleared K183204

Bone VCAR (BVCAR)

GE Medical Systems SCS

Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by...

Modality
CT/CTA
Anatomy
Spine
Decision
2019-04-08
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 K180091

UNiD Spine Analyzer

Medicrea International

Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Decision
2018-02-08
FDA-cleared K170172

UNiD Spine Analyzer

MEDICREA INTERNATIONAL

Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Decision
2017-05-24