DRX-Evolution/Plus With Dual Energy

System, X-ray, Stationary

Carestream Health, Inc.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Drx-evolution/plus With Dual Energy.

Pre-market Notification Details

Device IDK190330
501k NumberK190330
Device Name:DRX-Evolution/Plus With Dual Energy
ClassificationSystem, X-ray, Stationary
Applicant Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
ContactCarolyn Wagner
CorrespondentCarolyn Wagner
Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-14
Decision Date2019-11-04

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