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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 / K260169

510(k) cleared

AV Cardiac CT

Philips Medical Systems Nederland B.V. · Mar 5, 2026 · K260169

FDA cleared the AV Cardiac CT from Philips Medical Systems Nederland B.V. on Mar 5, 2026 under K260169, 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 Jan 20, 2026. The decision came 44 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 K260169?

K260169 is the FDA 510(k) for AV Cardiac CT, submitted by Philips Medical Systems Nederland B.V.. FDA's decision date was Mar 5, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the AV Cardiac CT?

Philips Medical Systems Nederland B.V., based in Best, is the applicant of record for K260169.

How long did the K260169 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Mar 5, 2026, 44 days later.

← All decisions in March 2026