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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
Recalls CDRH Recalls
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