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..
FDA 510(k) Cleared Radiological Computer-assisted Triage And Notification Software Devices (Product Code QAS)
About Product Code QAS - Regulatory Context
510(k) Submission Activity
84 total 510(k) submissions under product code QAS since 2018, with 83 receiving FDA clearance (average review time: 119 days).
Submission volume has remained relatively stable over the observed period, with 30 submissions in the last 24 months.
FDA Review Time
FDA review times for QAS submissions have been consistent, averaging 121 days recently vs 118 days historically.
QAS devices are reviewed by the Radiology panel. Browse all Radiology devices →