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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 / K253963

510(k) cleared

Cubresa BrainPET

Cubresa, Inc. · Jul 17, 2026 · K253963

FDA cleared the Cubresa BrainPET from Cubresa, Inc. on Jul 17, 2026 under K253963, a traditional 510(k). The device falls under product code OUO, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 11, 2025. The decision came 218 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 Cubresa, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253963?

K253963 is the FDA 510(k) for Cubresa BrainPET, submitted by Cubresa, Inc.. FDA's decision date was Jul 17, 2026, under product code OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance).

Who makes the Cubresa BrainPET?

Cubresa, Inc., based in Winnipeg, is the applicant of record for K253963.

How long did the K253963 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Jul 17, 2026, 218 days later.

← All decisions in July 2026