510(k) K242519

Lumify Diagnostic Ultrasound System by Philips Ultrasound — Product Code IYN

K242519 is an FDA 510(k) premarket notification submitted by Philips Ultrasound for the device "Lumify Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on May 15, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Philips Ultrasound has at least 10 other 510(k) clearances on record.