FDA Product Code QAS: Radiological Computer-assisted Triage And Notification Software
FDA product code QAS covers radiological computer-assisted triage and notification software.
These AI-powered tools automatically analyze radiological images and prioritize cases based on the likelihood of critical findings — such as intracranial hemorrhage, pneumothorax, or pulmonary embolism. They alert radiologists and clinicians to urgent cases, reducing time to diagnosis and treatment.
QAS devices are Class II medical devices, regulated under 21 CFR 892.2080 and reviewed by the FDA Radiology panel.
Leading manufacturers include Aidoc Medical , Ltd., Ischemaview, Inc. and Siemens Medical Solutions USA, Inc..
List of Radiological Computer-assisted Triage And Notification Software devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Radiological Computer-assisted Triage And Notification Software devices (product code QAS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →