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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 / October 2025 / K252645

510(k) cleared

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

Philips Medical Systems Nederland B.V. · Oct 24, 2025 · K252645

FDA cleared the LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub from Philips Medical Systems Nederland B.V. on Oct 24, 2025 under K252645, a abbreviated 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 21, 2025. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).

Philips Medical Systems Nederland B.V. has 8 other decisions in the tracker over the last 12 months: K254205 (Zenition 30), K262330 (dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T), K262294 (dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T), K260207 (Multimodality Simulation Workspace (MM Sim) (v1.0.0)).

Questions & Answers

What did FDA clear under K252645?

K252645 is the FDA 510(k) for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub, submitted by Philips Medical Systems Nederland B.V.. FDA's decision date was Oct 24, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

Philips Medical Systems Nederland B.V., based in Best, is the applicant of record for K252645.

How long did the K252645 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Oct 24, 2025, 64 days later.

← All decisions in October 2025