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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, fluoroscopic, image-intensified
510(k) Number K081091
Device Name PRECISION 500D R&F X-RAY SYSTEM
Original Applicant
GE HEALTHCARE
3000 n grandview blvd.
w-709
waukesha,  WI  53188
Original Contact michael petrowski
Regulation Number892.1650
Classification Product Code
JAA  
Date Received04/16/2008
Decision Date 06/11/2008
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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