Modality
120 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Crescom Co., Ltd.
Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee...
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...
AZmed
Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.
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...
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...
Overjet, Inc.
Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.
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,...
Crescom Co., Ltd.
View and quantify bone age from 2D posteroanterior left-hand radiographs to aid pediatric radiologists assessing patients aged 2-18 years.
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,...
Pearl, Inc.
Second Opinion Panoramic is an automated image-processing aid that identifies and marks regions of interest for caries, periapical radiolucency, and impacted third molars on...
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...
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...
VideaHealth Inc.
Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical...
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...
Velmeni Inc.
Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in...
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...
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...
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...
Siemens Medical Solutions
YSIO X.pree is a digital X-ray system for whole-body radiographic imaging, including skull, chest, abdomen, and extremities, to support diagnostic and therapeutic decisions.
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...
Audax d.o.o.
AudaxCeph Cephalogram Analysis Software assists specialized dental practices with storing and presenting patient cephalogram images and treatment planning through landmark...
Smart Soft Healthcare AD
Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.
Cube Click, Inc.
Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental...
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...
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;...
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...
AZmed
Second-reader support for radiologists reviewing adult digital AP or PA chest radiographs, with suspected pulmonary nodules in the 6-30 mm range marked for review.
AZmed
Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.
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...
Gleamer SAS
Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.
Ever Fortune.AI, Co., Ltd.
Passive triage of adult AP chest radiographs for an endotracheal-tube tip more than 7 cm above the carina, less than 3 cm above the carina, below the carina in the right or left...
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...
Milvue
Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle,...
Pearl Inc.
Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older,...
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...
Vuno Inc.
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence...
Overjet Inc
Overjet Image Enhancement Assist provides optional image-quality enhancement for dental radiographs. The FDA material describes learning-based noise reduction for bitewing and...
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,...
Overjet, Inc
Dental radiograph charting assistance for detecting natural and restorative dental structures and tooth numbering on bitewing, periapical, and panoramic images.
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...
Disior Ltd
Foot and ankle radiograph analysis for orthopaedic visualization, measurements, and preoperative surgical planning by qualified professionals.
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...
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...
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...
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,...
Milvue
Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...
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...
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...
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...
Orca Dental AI LTD
Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.
Envisionit DeepAI Ltd
Passively triage adult frontal chest X-rays for suspected pleural effusion and/or pneumothorax by providing case-level PACS worklist output; not a standalone clinical-decision...
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...
Qure.ai Technologies
Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population
VideaHealth, Inc.
Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and...
Nobel Biocare AB
Acquire, manage, transfer, analyze, display, enhance, store, and communicate dental and craniomaxillofacial image information for diagnosis and treatment planning, restorative...
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...
Bering Ltd
Passive worklist triage for suspected pleural effusion and/or pneumothorax in adult chest radiographs
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...
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...
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...
Qure.ai Technologies
Automated measurement of cardiac diameter, thoracic diameter, and the cardiothoracic ratio (CTR) on posterior-anterior chest X-rays to aid physicians or licensed practitioners;...
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...
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...
Alpha Intelligence Manifolds, Inc.
DeepXray is a fully automated CR or DX radiographic image-processing device intended to aid trained medical professionals in measuring minimum joint-space width, assessing...
Qure.ai Technologies
Analyze adult frontal chest X-ray images for suspected pleural effusion and/or pneumothorax and provide case-level passive output for PACS/workstation worklist prioritization or...
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...
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...
IB Lab GmbH
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment...
GE Medical Systems, LLC
Critical Care Suite with Pneumothorax Detection AI Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the...
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,...
Annalise-AI Pty Ltd
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
Annalise-AI Pty Ltd
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
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...
Medipixel, Inc.
Quantified results from X-ray angiographic images of the coronary arteries to support clinical decisions about diagnosis or treatment evaluation in adult patients with coronary...
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,...
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...
Quanta Computer Inc.
QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.
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...
Aidoc Medical, Ltd.
BriefCase analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the...
Ever Fortune AI Co., Ltd.
EFAI PNXXR is a software workflow tool designed to aid the clinical assessment of adult (22 years of age or older). Posteroanterior (PA) view Chest X-Ray cases with features...
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...
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...
Ever Fortune.AI Co., Ltd.
EFAI Chestsuite XR Pleural Effusion Assessment System is a software workflow tool designed to aid the clinical assessment of adult (18 years of age or older) Chest X-Ray cases...
VinBrain Joint Stock Company
The DrAidTM for Radiology v1 is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with...
AZmed SAS
Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for...
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...
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...
Ever Fortune. AI Co., Ltd.
Automatic cardiothoracic-ratio assessment on PA chest X-ray images for adults 20-80 years old in healthcare institutions; results support clinician assessment and are not for...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of Chest X-Ray images in adults or transitional adolescents aged 18...
Riverain Technologies, Inc.
ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and...
Pearl Inc.
Second Opinion is a concurrent-reading aid for dental professionals reviewing bitewing and periapical radiographs of permanent teeth in patients aged 12 years and older.
Gleamer
BoneView is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.
Annalise-AI
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
OXOS Medical, Inc.
Micro C Medical Imaging System M01 is a handheld or portable general-purpose X-ray system for qualified clinicians to obtain diagnostic static or serial radiographic exposures of...
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...
Qure.ai Technologies
The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on...
Zebra Medical Vision Ltd.
The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Raycases with features suggestive of pneumoperitoneum in the...
Lunit Inc.
Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected...
GE Medical Systems, LLC
Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system. Critical Care Suite with the...
Canon Inc.
Intelligent NR is a radiographic image-processing function for supported X-ray studies in the exact K212269 workflow; processed images are reviewed by qualified professionals and...
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...
Radiobotics ApS
The Radiobotics' Rbknee is a fully -automated image processing software device intended to aid medical professionals in the analysis and reporting of weight-bearing AP/PA...
Imagen Technologies, Inc
Concurrent CADe reading aid that identifies, categorizes, and highlights suspicious regions of interest on adult chest radiographs
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...
Carestream Health, Inc.
Eclipse II with Smart Noise Cancellation digitally enhances radiographic images generated by supported X-ray devices for adult and pediatric use; the cleared function is for...
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...
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...
RADLogics, Inc.
The AIMI-Triage CXR PTX Application is a notification-only triage workflow toll for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in...
Behold.AI Technologies Limited
The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the...
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...
Zebra Medical Vision, Ltd.
The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-ray cases with features suggestive of pleural effusion in the...
IB Lab GmbH
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features...
GE Medical Systems, LLC.
Computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite...
Zebra Medical Vision Ltd.
The Zebra Pneumothorax device is a software tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care...
Imagen Technologies, Inc.
Computer-aided detection and localization of distal radius fractures on adult wrist PA/LAT radiographs as an adjunct to clinician review.
SIEMENS MEDICAL SOLUTIONS USA, INC.
YSIO MAX is a digital radiography system for whole-body skull, chest, abdomen, and extremity imaging in pediatric, adult, and bariatric patients, including supported emergency and...
RIVERAIN TECHNOLOGIES
Generation of an enhanced secondary chest radiograph to facilitate confirmation and localization of lines and tubes; adjunctive information, not a substitute for the original...
RIVERAIN MEDICAL GROUP,LLC
DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.
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...
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...