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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
Recalls CDRH Recalls
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