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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 K090318
Device Name CARESTREAM DRX-1 SYSTEM
Applicant
CARESTREAM HEALTH, INC.
1049 WEST RIDGE ROAD
ROCHESTER,  NY  14615
Applicant Contact CHRISTINE EHMANN
Correspondent
CARESTREAM HEALTH, INC.
1049 WEST RIDGE ROAD
ROCHESTER,  NY  14615
Correspondent Contact CHRISTINE EHMANN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/09/2009
Decision Date 04/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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