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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 / K260519

510(k) cleared

Smart Fit TorsoCardiac 1.5T

Philips Healthcare (Suzhou) Co., Ltd. · Mar 20, 2026 · K260519

FDA cleared the Smart Fit TorsoCardiac 1.5T from Philips Healthcare (Suzhou) Co., Ltd. on Mar 20, 2026 under K260519, a special 510(k). The device falls under product code MOS, Coil, Magnetic Resonance, Specialty, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 17, 2026. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

Philips Healthcare (Suzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K252992 (CT Rembra RT; CT Areta RT; CT Rembra).

Questions & Answers

What did FDA clear under K260519?

K260519 is the FDA 510(k) for Smart Fit TorsoCardiac 1.5T, submitted by Philips Healthcare (Suzhou) Co., Ltd.. FDA's decision date was Mar 20, 2026, under product code MOS (Coil, Magnetic Resonance, Specialty).

Who makes the Smart Fit TorsoCardiac 1.5T?

Philips Healthcare (Suzhou) Co., Ltd., based in Suzhou, is the applicant of record for K260519.

How long did the K260519 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Mar 20, 2026, 31 days later.

← All decisions in March 2026

Sources