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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
Applicant
GE Healthcare
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Applicant Contact MICHAEL PETROWSKI
Correspondent
GE Healthcare
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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