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
Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
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...
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.
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
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
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...
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
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
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...
Photonova Spectra and Spectra Select are silicon-based spectral photon-counting detector CT systems that acquire cross-sectional body images, multienergy data, monochromatic...
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...
eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...
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...
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
Diagnocat is an automated concurrent-read aid for detecting periapical radiolucency on permanent teeth in previously acquired, clinically justified maxillofacial CBCT; it is a...
BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating...
Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring...
cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the...
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...
Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in...
Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.
Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis exams to identify and mark soft-tissue densities (masses, architectural distortions, asymmetries) and...
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.
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...
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...
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
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...
Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental...
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;...
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
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
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...
Post-processing automatic segmentation, quantification, and reporting of brain FLAIR hyperintensity volumes to support structural MRI review; not disease detection or diagnosis.
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...
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...
Better Diagnostics Caries Assist is a concurrent-read computer-aided detection device that identifies and localizes carious lesions on bitewing and periapical radiographs of...
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...
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
Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and...
Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle,...
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
Concurrent reading aid for interpreting physicians on screening DBT mammograms to detect and characterize soft-tissue lesions and calcifications that may indicate cancer.
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...
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.
Concurrent CAD/CADx aid for interpreting physicians reading compatible DBT exams to detect soft-tissue densities and calcifications for physician confirmation or dismissal.
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,...
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, in adults or...
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
Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.
PIUR tUS Infinity supports a computer-aided thyroid ultrasound workflow that identifies thyroid lobes and margins, calculates volume, marks and quantifies nodules, and provides...
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
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...
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
Dental radiograph charting assistance for detecting natural and restorative dental structures and tooth numbering on bitewing, periapical, and panoramic images.
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
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...
Briefcase-Triage is a radiological computer- aided triage and notification software indicated for use in the analysis of CTPA images, in adults or transitional adolescents aged 18...
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...
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
AI-Rad Companion Pulmonary is image-processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and...
Modality
CT/CTA
Anatomy
Adult lungs, lung lobes, pulmonary parenchyma, and solid or sub-solid lung nodules
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...
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...
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)
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
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
Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.
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...
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...
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
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...
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...
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
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...
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...
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
uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...
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...
Assist radiologists in detecting solid and subsolid pulmonary nodules during review of multivendor multi-detector CT examinations of the chest; the device is an adjunctive first-...
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
Imbio CAC Software 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...
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...
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to...
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
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...
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is...
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...
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities...
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
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
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
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
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...
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...
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
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and...
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support...
Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or...
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...
Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for...
Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended...
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents...
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...
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...
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
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
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...
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...
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...
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients...
Aid interpreting physicians in detecting, localizing, and characterizing suspicious breast-cancer areas on mammograms from compatible FFDM systems, viewed after the physician...
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...
Stroke SENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist...
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...
Samsung V8 is a general diagnostic ultrasound system for broad hospital, clinic, and practice applications; K211945 adds thoracic scanning, AI-based NerveTrack, and AI-based...
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...
EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm,...
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of Non-Enhanced Head CT images. The device is intended to assist...
Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...
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.
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.
Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided...
LVivo Software Application non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients...
Modality
Ultrasound
Anatomy
Structures and function represented in supported ultrasound examinations
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
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...
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...
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
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...
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
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...
CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...
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...
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...
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...
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,...
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...
PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while...
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
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...
Concurrent computer-aided detection for radiologists interpreting compatible GE Senoclaire breast tomosynthesis examinations, with detected soft-tissue densities blended into the...
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation...
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
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...
Non-invasive processing of previously acquired echocardiographic images to detect and measure the left-ventricular wall and calculate left-ventricular function.
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...
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...
LOGICON Caries Detector is adjunct software for detecting caries extending into dentin on unrestored proximal surfaces of secondary dentition in supported digital intraoral...