Lumify Diagnostic Ultrasound System

Lumify Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K203406) manufactured by Philips Ultrasound, 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 February 22, 2021. Regulation: 8.