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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 / July 2026 / K253670

510(k) cleared

SmartCT (R3.0 (L10))

Philips Medical Systems B.V. · Jul 10, 2026 · K253670

FDA cleared the SmartCT (R3.0 (L10)) from Philips Medical Systems B.V. on Jul 10, 2026 under K253670, a abbreviated 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 Nov 21, 2025. The decision came 231 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: K253649 (Spectral CT Verida Family), K254186 (Azurion R3.1), K251827 (Azurion R3.1).

Questions & Answers

What did FDA clear under K253670?

K253670 is the FDA 510(k) for SmartCT (R3.0 (L10)), submitted by Philips Medical Systems B.V.. FDA's decision date was Jul 10, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the SmartCT (R3.0 (L10))?

Philips Medical Systems B.V., based in Best, is the applicant of record for K253670.

How long did the K253670 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jul 10, 2026, 231 days later.

← All decisions in July 2026

Sources