CONVIVO In Vivo Pathology Suite

System, Image Processing, Radiological

Carl Zeiss Meditec AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Convivo In Vivo Pathology Suite.

Pre-market Notification Details

Device IDK211156
510k NumberK211156
Device Name:CONVIVO In Vivo Pathology Suite
ClassificationSystem, Image Processing, Radiological
Applicant Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena,  DE D-07445
ContactJuergen Berger
CorrespondentMaria Golovina
Carl Zeiss Meditec Inc 5300 Central Parkway Dublin,  CA  94568
Product CodeLLZ  
Subsequent Product CodeGWG
Subsequent Product CodeOWN
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-04-19
Decision Date2021-12-29

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