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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 / November 2025 / K253495

510(k) cleared

syngo.MR Applications (VB80)

Siemens Healthineers AG · Nov 20, 2025 · K253495

FDA cleared the syngo.MR Applications (VB80) from Siemens Healthineers AG on Nov 20, 2025 under K253495, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 28, 2025. The decision came 23 days later, inside the 90 FDA-day goal for a 510(k).

Siemens Healthineers AG has 4 other decisions in the tracker over the last 12 months: K260852 (MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure), K253690 (LungMaps), K253023 (BIOGRAPH One), K251059 (Syngo Carbon Clinicals (VA41)).

Questions & Answers

What did FDA clear under K253495?

K253495 is the FDA 510(k) for syngo.MR Applications (VB80), submitted by Siemens Healthineers AG. FDA's decision date was Nov 20, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the syngo.MR Applications (VB80)?

Siemens Healthineers AG, based in Forchheim, is the applicant of record for K253495.

How long did the K253495 review take?

FDA received the submission on Oct 28, 2025 and issued its decision on Nov 20, 2025, 23 days later.

← All decisions in November 2025

Sources