TABLET VIEWER SOFTWARE FOR IMAGE SUITE

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 Tablet Viewer Software For Image Suite.

Pre-market Notification Details

Device IDK140271
510k NumberK140271
Device Name:TABLET VIEWER SOFTWARE FOR IMAGE SUITE
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 Received2014-02-03
Decision Date2014-04-01
Summary:summary

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