CARESTREAM VUE PACS

System, Image Processing, Radiological

CARESTREAM HEALTH, INC.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Vue Pacs.

Pre-market Notification Details

Device IDK122523
510k NumberK122523
Device Name:CARESTREAM VUE PACS
ClassificationSystem, Image Processing, Radiological
Applicant CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester,  NY  14608
ContactAlexandra Chamberlain
CorrespondentAlexandra Chamberlain
CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester,  NY  14608
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-20
Decision Date2012-10-23

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