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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K050704
Device Name MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact JOHN L SCHMIDT
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact JOHN L SCHMIDT
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received03/18/2005
Decision Date 04/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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