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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, Mobile
510(k) Number K103476
Device Name BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
Applicant
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact NIDHI CHAUDHARY
Correspondent
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact NIDHI CHAUDHARY
Regulation Number892.1720
Classification Product Code
IZL  
Date Received11/24/2010
Decision Date 06/16/2011
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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