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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 / August 2026 / K261228

510(k) cleared

QuickVision Ultimate rTMS

Brain Ultimate, Inc. · Aug 14, 2026 · K261228

FDA cleared the QuickVision Ultimate rTMS from Brain Ultimate, Inc. on Aug 14, 2026 under K261228, a traditional 510(k). The device falls under product code OBP, Transcranial Magnetic Stimulator, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 15, 2026. The decision came 121 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Brain Ultimate, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261228?

K261228 is the FDA 510(k) for QuickVision Ultimate rTMS, submitted by Brain Ultimate, Inc.. FDA's decision date was Aug 14, 2026, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the QuickVision Ultimate rTMS?

Brain Ultimate, Inc., based in Alpharetta, GA, is the applicant of record for K261228.

How long did the K261228 review take?

FDA received the submission on Apr 15, 2026 and issued its decision on Aug 14, 2026, 121 days later.

← All decisions in August 2026