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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K252558

510(k) cleared

Lumify Diagnostic Ultrasound System

Philips Ultrasound, LLC · May 5, 2026 · K252558

FDA cleared the Lumify Diagnostic Ultrasound System from Philips Ultrasound, LLC on May 5, 2026 under K252558, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 13, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Ultrasound, LLC has 8 other decisions in the tracker over the last 12 months: K262311 (Alturion Series Diagnostic Ultrasound System), K261211 (Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System), K260667 (Alturion Series Diagnostic Ultrasound System), K260123 (EPIQ Series Diagnostic Ultrasound System).

Questions & Answers

What did FDA clear under K252558?

K252558 is the FDA 510(k) for Lumify Diagnostic Ultrasound System, submitted by Philips Ultrasound, LLC. FDA's decision date was May 5, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Lumify Diagnostic Ultrasound System?

Philips Ultrasound, LLC, based in Bothell, WA, is the applicant of record for K252558.

How long did the K252558 review take?

FDA received the submission on Aug 13, 2025 and issued its decision on May 5, 2026, 265 days later.

← All decisions in May 2026