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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K260694
Device Name ZEISS CLINIC 360
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact Todd Milholland
Correspondent
Carl Zeiss Meditec USA, Inc.
5300 Central Pkwy.
Dublin,  CA  94568
Correspondent Contact Marysa Lyew
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received03/03/2026
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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