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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 / K251827

510(k) cleared

Azurion R3.1

Philips Medical Systems B.V. · Oct 24, 2025 · K251827

FDA cleared the Azurion R3.1 from Philips Medical Systems B.V. on Oct 24, 2025 under K251827, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 13, 2025. The decision came 133 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Medical Systems B.V. has 3 other decisions in the tracker over the last 12 months: K253670 (SmartCT (R3.0 (L10))), K253649 (Spectral CT Verida Family), K254186 (Azurion R3.1).

Questions & Answers

What did FDA clear under K251827?

K251827 is the FDA 510(k) for Azurion R3.1, submitted by Philips Medical Systems B.V.. FDA's decision date was Oct 24, 2025, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the Azurion R3.1?

Philips Medical Systems B.V., based in Best, is the applicant of record for K251827.

How long did the K251827 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Oct 24, 2025, 133 days later.

← All decisions in October 2025

Sources