CARESTREAM DRYVIEW 5850 LASER IMAGER

Camera, Multi Format, Radiological

CARESTREAM HEALTH, INC.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Dryview 5850 Laser Imager.

Pre-market Notification Details

Device IDK090469
510k NumberK090469
Device Name:CARESTREAM DRYVIEW 5850 LASER IMAGER
ClassificationCamera, Multi Format, Radiological
Applicant CARESTREAM HEALTH, INC. 1 IMATION WAY 304-4B-28 Oakdale,  MN  55128 -3414
ContactGayle Carroll
CorrespondentGayle Carroll
CARESTREAM HEALTH, INC. 1 IMATION WAY 304-4B-28 Oakdale,  MN  55128 -3414
Product CodeLMC  
CFR Regulation Number892.2040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-23
Decision Date2009-05-22
Summary:summary

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