Carestream DRX-Evolution

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 Carestream Drx-evolution.

Pre-market Notification Details

Device IDK163203
510k NumberK163203
Device Name:Carestream DRX-Evolution
ClassificationSystem, X-ray, Stationary
Applicant Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
ContactCarolyn L. Wagner
CorrespondentCarolyn L. Wagner
Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-15
Decision Date2016-12-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.