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Radiological Computer-Assisted Prioritization Software For Lesions

FDA product code QFM · 41 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2080
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-03-08 – 2026-07-08

Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.

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