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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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