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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K122694
Device Name GE 8CH FOOT ANKLE COIL
Original Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
3200 n grandview blvd
mail code-w-827
waukesha,  WI  53188
Original Contact glen sabin
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/04/2012
Decision Date 10/25/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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