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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 / January 2026 / K254186

510(k) cleared

Azurion R3.1

Philips Medical Systems B.V. · Jan 16, 2026 · K254186

FDA cleared the Azurion R3.1 from Philips Medical Systems B.V. on Jan 16, 2026 under K254186, a special 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 Dec 23, 2025. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

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), K251827 (Azurion R3.1).

Questions & Answers

What did FDA clear under K254186?

K254186 is the FDA 510(k) for Azurion R3.1, submitted by Philips Medical Systems B.V.. FDA's decision date was Jan 16, 2026, 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 K254186.

How long did the K254186 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Jan 16, 2026, 24 days later.

← All decisions in January 2026

Sources