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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 K051967
Device Name REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
Applicant
GE HEALTHCARE
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JOHN L SCHMIDT
Correspondent
GE HEALTHCARE
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact JOHN L SCHMIDT
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
IZF   MQB  
Date Received07/20/2005
Decision Date 08/09/2005
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
Recalls CDRH Recalls
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