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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 / K260500

510(k) cleared

ResolutionMD

ResolutionMD, Inc. · Jul 21, 2026 · K260500

FDA cleared the ResolutionMD from ResolutionMD, Inc. on Jul 21, 2026 under K260500, a traditional 510(k). 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 Feb 13, 2026. The decision came 158 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 ResolutionMD, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260500?

K260500 is the FDA 510(k) for ResolutionMD, submitted by ResolutionMD, Inc.. FDA's decision date was Jul 21, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the ResolutionMD?

ResolutionMD, Inc., based in Calgary, is the applicant of record for K260500.

How long did the K260500 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Jul 21, 2026, 158 days later.

← All decisions in July 2026