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THE TAPE

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 / K260316

510(k) cleared

CMN Capillary Function with Oncology Virtual Expert

Cercare Medical A/S · Jun 22, 2026 · K260316

FDA cleared the CMN Capillary Function with Oncology Virtual Expert from Cercare Medical A/S on Jun 22, 2026 under K260316, 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 Jan 30, 2026. The decision came 143 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: K253831 (CMN Capillary Function with Virtual Expert for MRI, CT and CBCT).

Questions & Answers

What did FDA clear under K260316?

K260316 is the FDA 510(k) for CMN Capillary Function with Oncology Virtual Expert, submitted by Cercare Medical A/S. FDA's decision date was Jun 22, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the CMN Capillary Function with Oncology Virtual Expert?

Cercare Medical A/S, based in Aarhus C, is the applicant of record for K260316.

How long did the K260316 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Jun 22, 2026, 143 days later.

← All decisions in June 2026

Sources