WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / November 2025 / K251822

510(k) cleared

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance , Ltd. · Nov 20, 2025 · K251822

FDA cleared the MAGNETOM Free.Max; MAGNETOM Free.Star from Siemens Shenzhen Magnetic Resonance , Ltd. on Nov 20, 2025 under K251822, a traditional 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 Jun 13, 2025. The decision came 160 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Shenzhen Magnetic Resonance , Ltd. has one other decision in the tracker over the last 12 months: K260265 (MAGNETOM Flow.Ace; MAGNETOM Flow.Plus).

Questions & Answers

What did FDA clear under K251822?

K251822 is the FDA 510(k) for MAGNETOM Free.Max; MAGNETOM Free.Star, submitted by Siemens Shenzhen Magnetic Resonance , Ltd.. FDA's decision date was Nov 20, 2025, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the MAGNETOM Free.Max; MAGNETOM Free.Star?

Siemens Shenzhen Magnetic Resonance , Ltd., based in Shenzhen, is the applicant of record for K251822.

How long did the K251822 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Nov 20, 2025, 160 days later.

← All decisions in November 2025

Sources