Device type

Radiological Computer-Assisted Triage And Notification Software

Product code QAS · Class II · 21 CFR 892.2080 · Radiology

Radiological computer-assisted triage and notification software 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 .

FDA classification database