Imagen Technologies, Inc radiology AI products

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FDA-cleared K230085

Lung-CAD

Imagen Technologies, Inc

Authorized purpose: 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 identify regions of interest (ROIs) with lung hyperinflation and produces boxes around the ROIs. Lung-CAD is intended for use as a concurrent reading aid for physicians interpreting chest X-rays. The device is not intended for clinical diagnosis of any disease. It does not replace the role of the physician or of other diagnostic testing in the standard of care for lung parenchymal findings. Lung-CAD is indicated for adults only.

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-10-03

Detection and CADe

FDA-cleared K223811

Lung-CAD

Imagen Technologies, Inc

Authorized purpose: 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 clinical diagnosis or replace physician review or other tests.

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-09-13

Detection and CADe

FDA-cleared K213353

Aorta-CAD

Imagen Technologies, Inc

Authorized purpose: Concurrent-read CADe to aid physicians in detecting and localizing chest-radiograph ROIs labeled aortic calcification or dilated aorta, suggestive of aortic atherosclerosis or aortic ectasia; it does not replace the physician or other standard-of-care testing.

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

Authorized purpose: 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 imaging MSK and bone Detection and CADe

FDA-cleared K193417

FractureDetect (FX)

Imagen Technologies, Inc.

Authorized purpose: Assists clinicians in detecting fractures during review of adult musculoskeletal radiographs.

Modality: X-ray/Radiography
Anatomy: MSK
Decision: 2020-07-30

MSK and bone Detection 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 bone Detection and CADe