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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K061953
Device Name 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
Applicant
Ge Oec Medical Systems
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact GREG HANSEN
Correspondent
Ge Oec Medical Systems
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact GREG HANSEN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received07/10/2006
Decision Date 08/15/2006
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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