BONE SUPPRESSION SOFTWARE

Solid State X-ray Imager (flat Panel/digital Imager)

CARESTREAM HEALTH, INC.

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

Pre-market Notification Details

Device IDK133442
510k NumberK133442
Device Name:BONE SUPPRESSION SOFTWARE
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester,  NY  14608
ContactCarolyn Wagner
CorrespondentCarolyn Wagner
CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester,  NY  14608
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-12
Decision Date2014-03-11
Summary:summary

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