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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 Processing, Radiological
510(k) Number K211156
Device Name CONVIVO In Vivo Pathology Suite
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE D-07445
Applicant Contact Juergen Berger
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublic,  CA  94568
Correspondent Contact Maria Golovina
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
GWG   OWN  
Date Received04/19/2021
Decision Date 12/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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