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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 K130464
Device Name CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
Applicant
CARESTREAM HEALTH,INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Applicant Contact CAROLYN WAGNER
Correspondent
CARESTREAM HEALTH,INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Correspondent Contact CAROLYN WAGNER
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/22/2013
Decision Date 06/07/2013
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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