Flash Ultrasound System 5100 Point of Care

Flash Ultrasound System 5100 Point of Care is an FDA 510(k)-cleared medical device (K250030) manufactured by Philips Ultrasound, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2025. Regulation: 8.