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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K183245
Device Name Carestream DRX-1 System with DRX Plus 2530 Detectors
Applicant
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Applicant Contact Gina L Maiolo
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact Gina L Maiolo
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/21/2018
Decision Date 02/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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