Butterfly iQ/iQ+ Ultrasound System

Butterfly iQ/iQ+ Ultrasound System is an FDA 510(k)-cleared medical device (K220068) manufactured by Butterfly Network, 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 March 30, 2023. Regulation: 8.