Radiological Computer-Assisted Prioritization Software For Lesions
QFM · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2080
Classification
FDA Product Code
QFM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.2080
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.