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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
Device Name TOSHIBA 3T 32CH HEAD SPEEDER COIL,
Applicant
QUALITY ELECTRODYNAMICS
700 BETA DRIVE
SUITE 100
MAYFIELD VILLAGE,  OH  44143 -0000
Applicant Contact Kathleen Aras
Correspondent
QUALITY ELECTRODYNAMICS
700 BETA DRIVE
SUITE 100
MAYFIELD VILLAGE,  OH  44143 -0000
Correspondent Contact Kathleen Aras
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/29/2012
Decision Date 09/25/2012
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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