Imagen Technologies, Inc.

Address:594 Broadway,New York,NY,10012,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Medical Image (MYN) (1) Radiological Computer Assisted Detection/Diagnosis Software For Fracture (QBS) (1)

Premarket Exempt

Clear

FractureDetect (FX) - 00852491008016 Catalog Number :

Device Description : FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) softwar 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 musculoskeletal system. FX is indicated for adults only.

Device Class : 2

Duns Number: 042356781

Premarket Exempt : No

Product Code : QBS

Prescription Use : No

Device Count : 1

Chest-CAD - 00852491008023 Catalog Number :

Device Description : Chest-CAD is a computer-assisted detection (CADe) software device designed as a Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016

Device Class : 2

Duns Number: 042356781

Premarket Exempt : No

Product Code : MYN

Prescription Use : No

Device Count : 1

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