Zeiss Clinic 360

FDA 510(k) K260694 · Carl Zeiss Meditec, AG

Substantially Equivalent

510(k) numberK260694

Submission

Device name
Zeiss Clinic 360
Applicant
Carl Zeiss Meditec, AG
Jena, DE
Received
March 3, 2026
Decision date
July 17, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFJ – System, Image Management, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Zeiss Clinic 360 cleared by the FDA?

Zeiss Clinic 360 (K260694) received a 510(k) decision of Substantially Equivalent on July 17, 2026, 136 days after the submission was received.

What is the product code of K260694?

The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.