Rapid PE Triage and Notification (PETN)

Rapid PE Triage and Notification (PETN) is an FDA 510(k)-cleared medical device (K220499) 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 May 16, 2022. Regulation: 8.