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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 K153142
Device Name Carestream DRX-1 System with DRX Plus 4343 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 VICTORIA WHEELER
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/30/2015
Decision Date 11/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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