Radiological Computer-Assisted Triage and Notification Software

What Is It?

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 .

How Is QAS Classified?

Radiological Computer-Assisted Triage And Notification Software is FDA product code QAS, Class 2, 21 CFR 892.2080.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 83 days from receipt to decision on them.