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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 K183474
Device Name Carestream DRX-1 System with DRX Core Detectors
Applicant
Carestream Health, Inc.
150 Verona Street
Rochester,  NY  14608
Applicant Contact Victoria Wheeler
Correspondent
Carestream Health, Inc.
150 Verona Street
Rochester,  NY  14608
Correspondent Contact Carolyn L Wagner
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/17/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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