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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 / June 2026 / K260406

510(k) cleared

Brainomix 360 Hyperdensity

Brainomix Limited · Jun 12, 2026 · K260406

FDA cleared the Brainomix 360 Hyperdensity from Brainomix Limited on Jun 12, 2026 under K260406, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 9, 2026. The decision came 123 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 Brainomix Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260406?

K260406 is the FDA 510(k) for Brainomix 360 Hyperdensity, submitted by Brainomix Limited. FDA's decision date was Jun 12, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Brainomix 360 Hyperdensity?

Brainomix Limited, based in Oxford, is the applicant of record for K260406.

How long did the K260406 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Jun 12, 2026, 123 days later.

← All decisions in June 2026