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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 / March 2026 / K253649

510(k) cleared

Spectral CT Verida Family

Philips Medical Systems Technologies , Ltd. · Mar 27, 2026 · K253649

FDA cleared the Spectral CT Verida Family from Philips Medical Systems Technologies , Ltd. on Mar 27, 2026 under K253649, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 20, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Medical Systems Technologies , Ltd. has 3 other decisions in the tracker over the last 12 months: K253670 (SmartCT (R3.0 (L10))), K254186 (Azurion R3.1), K251827 (Azurion R3.1).

Questions & Answers

What did FDA clear under K253649?

K253649 is the FDA 510(k) for Spectral CT Verida Family, submitted by Philips Medical Systems Technologies , Ltd.. FDA's decision date was Mar 27, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Spectral CT Verida Family?

Philips Medical Systems Technologies , Ltd., based in Haifa, is the applicant of record for K253649.

How long did the K253649 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Mar 27, 2026, 127 days later.

← All decisions in March 2026

Sources