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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 K122638
Model QA7000032 (QED P/N), QED000032 (QED P/N), MJAH-152A (TOSHIBA P/N)
Device Name TOSHIBA 3T 32CH HEAD SPEEDER COIL,
Original Applicant
QUALITY ELECTRODYNAMICS
700 beta drive
suite 100
mayfield village,  OH  44143 0000
Original Contact kathleen aras
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/29/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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