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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 / June 2026 / K260116

510(k) cleared

CustoMED Viewer

CustoMED , Ltd. · Jun 3, 2026 · K260116

FDA cleared the CustoMED Viewer from CustoMED , Ltd. on Jun 3, 2026 under K260116, 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 Jan 14, 2026. The decision came 140 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 CustoMED , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260116?

K260116 is the FDA 510(k) for CustoMED Viewer, submitted by CustoMED , Ltd.. FDA's decision date was Jun 3, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the CustoMED Viewer?

CustoMED , Ltd., based in Ramat Gan, is the applicant of record for K260116.

How long did the K260116 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Jun 3, 2026, 140 days later.

← All decisions in June 2026