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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 / K260694

510(k) cleared

ZEISS CLINIC 360

Carl Zeiss Meditec, AG · Jul 17, 2026 · K260694

FDA cleared the ZEISS CLINIC 360 from Carl Zeiss Meditec, AG on Jul 17, 2026 under K260694, a traditional 510(k). The device falls under product code NFJ, System, Image Management, Ophthalmic, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 3, 2026. The decision came 136 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carl Zeiss Meditec, AG has one other decision in the tracker over the last 12 months: K253834 (VISUREF 600).

Questions & Answers

What did FDA clear under K260694?

K260694 is the FDA 510(k) for ZEISS CLINIC 360, submitted by Carl Zeiss Meditec, AG. FDA's decision date was Jul 17, 2026, under product code NFJ (System, Image Management, Ophthalmic).

Who makes the ZEISS CLINIC 360?

Carl Zeiss Meditec, AG, based in Jena, is the applicant of record for K260694.

How long did the K260694 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Jul 17, 2026, 136 days later.

← All decisions in July 2026

Sources