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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 K042602
Device Name REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
Applicant
Ge Medical Systems, LLC
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact MARK M STAUFFER
Correspondent
Ge Medical Systems, LLC
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact MARK M STAUFFER
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/24/2004
Decision Date 01/13/2005
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
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