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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 / May 2026 / K253831

510(k) cleared

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Cercare Medical A/S · May 18, 2026 · K253831

FDA cleared the CMN Capillary Function with Virtual Expert for MRI, CT and CBCT from Cercare Medical A/S on May 18, 2026 under K253831, 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 Dec 1, 2025. The decision came 168 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cercare Medical A/S has one other decision in the tracker over the last 12 months: K260316 (CMN Capillary Function with Oncology Virtual Expert).

Questions & Answers

What did FDA clear under K253831?

K253831 is the FDA 510(k) for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT, submitted by Cercare Medical A/S. FDA's decision date was May 18, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

Cercare Medical A/S, based in Aarhus C, is the applicant of record for K253831.

How long did the K253831 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on May 18, 2026, 168 days later.

← All decisions in May 2026

Sources