86 devices · 38 companies · 2018 to 2026

Product code QAS: Radiological Computer-Assisted Triage And Notification Software

86 devices under product code QAS, 2018 to 2026, from 38 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (85 of 86 here), the regulation, and MAUDE report counts by product code.

Radiological Computer-Assisted Triage And Notification Software. 21 CFR 892.2080, Class II. 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 . MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved 2026-10-29 from FDA public records.