Rapid Aneurysm Triage and Notification

Rapid Aneurysm Triage and Notification is an FDA 510(k)-cleared medical device (K230074) manufactured by Ischemaview, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2023. Regulation: 8.