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 Ever Fortune.Ai, Co., Ltd..