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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 / July 2026 / K260852

510(k) cleared

MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure

Siemens Healthineers AG · Jul 31, 2026 · K260852

FDA cleared the MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure from Siemens Healthineers AG on Jul 31, 2026 under K260852, 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 Mar 16, 2026. The decision came 137 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Healthineers AG has 4 other decisions in the tracker over the last 12 months: K253690 (LungMaps), K253023 (BIOGRAPH One), K253495 (syngo.MR Applications (VB80)), K251059 (Syngo Carbon Clinicals (VA41)).

Questions & Answers

What did FDA clear under K260852?

K260852 is the FDA 510(k) for MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure, submitted by Siemens Healthineers AG. FDA's decision date was Jul 31, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure?

Siemens Healthineers AG, based in Forchheim, is the applicant of record for K260852.

How long did the K260852 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Jul 31, 2026, 137 days later.

← All decisions in July 2026

Sources