CARESTREAM 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 Pacs.

Pre-market Notification Details

Device IDK110919
510k NumberK110919
Device Name:CARESTREAM PACS
ClassificationSystem, Image Processing, Radiological
Applicant CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester,  NY  14608
ContactLinda Stewart
CorrespondentLinda Stewart
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 Received2011-04-01
Decision Date2011-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60889971047809 K110919 000
60889971041692 K110919 000
00884838100336 K110919 000

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