DeviceClearance

Product code QAS— Radiology

BriefCase

Classification name
Radiological Computer-Assisted Triage And Notification Software
Device class
Class 2
Regulation
21 CFR 892.2080
Advisory panel
Radiology
Total cleared
87
First cleared
Most recent

FDA classification definition

“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 .”

— U.S. Food and Drug Administration, device classification record for product code QAS under 21 CFR 892.2080, via openFDA

Market context for product code QAS

FDA has cleared 87 devices under product code QAS between 2018 and 2026, filed by 31 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QAS

Recent clearances under product code QAS

Data sourced from openFDA. This site is unofficial and independent of the FDA.