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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 / February 2026 / K251474

510(k) cleared

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies · Feb 6, 2026 · K251474

FDA cleared the Median LCS (internal name) / eyonis LCS (trade name) (1.0) from Median Technologies on Feb 6, 2026 under K251474, a traditional 510(k). The device falls under product code QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 13, 2025. The decision came 269 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 Median Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251474?

K251474 is the FDA 510(k) for Median LCS (internal name) / eyonis LCS (trade name) (1.0), submitted by Median Technologies. FDA's decision date was Feb 6, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the Median LCS (internal name) / eyonis LCS (trade name) (1.0)?

Median Technologies, based in Valbonne, is the applicant of record for K251474.

How long did the K251474 review take?

FDA received the submission on May 13, 2025 and issued its decision on Feb 6, 2026, 269 days later.

← All decisions in February 2026