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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 / February 2026 / K260265

510(k) cleared

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance , Ltd. · Feb 23, 2026 · K260265

FDA cleared the MAGNETOM Flow.Ace; MAGNETOM Flow.Plus from Siemens Shenzhen Magnetic Resonance , Ltd. on Feb 23, 2026 under K260265, a special 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 28, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Siemens Shenzhen Magnetic Resonance , Ltd. has one other decision in the tracker over the last 12 months: K251822 (MAGNETOM Free.Max; MAGNETOM Free.Star).

Questions & Answers

What did FDA clear under K260265?

K260265 is the FDA 510(k) for MAGNETOM Flow.Ace; MAGNETOM Flow.Plus, submitted by Siemens Shenzhen Magnetic Resonance , Ltd.. FDA's decision date was Feb 23, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the MAGNETOM Flow.Ace; MAGNETOM Flow.Plus?

Siemens Shenzhen Magnetic Resonance , Ltd., based in Shenzhen, is the applicant of record for K260265.

How long did the K260265 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Feb 23, 2026, 26 days later.

← All decisions in February 2026

Sources