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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 K182318
Device Name Retina Workplace
Applicant
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact Maria Golovina
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact Maria Golovina
Regulation Number892.2050
Classification Product Code
NFJ  
Subsequent Product Codes
HKI   OBO  
Date Received08/27/2018
Decision Date 10/24/2018
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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