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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 (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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