Radiology AI Directory

Vendor

Imagen Technologies, Inc

6 FDA-cleared listings in this directory.

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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
Detection and CADe
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
Detection and CADe
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
Detection and CADe
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
Cardiac imagingMSK and boneDetection and CADe
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
MSK and boneDetection and CADe
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
MSK and boneDetection and CADe