Lumify Diagnostic Ultrasound System

Lumify Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K252558) 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 May 4, 2026. Regulation: 8.