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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 K180858
Device Name CALLISTO eye
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer St. 51-52
Jena,  DE 07745
Applicant Contact Christian Muenster
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact Mandy Ambrecht
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received04/02/2018
Decision Date 06/27/2018
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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