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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 K120627
Device Name TOSHIBA 1.5T QD HEAD COIL
Applicant
QUALITY ELECTRODYNAMICS
700 beta drive
suite 100
mayfield village,  OH  44143 -0000
Applicant Contact christie zydyk
Correspondent
QUALITY ELECTRODYNAMICS
700 beta drive
suite 100
mayfield village,  OH  44143 -0000
Correspondent Contact christie zydyk
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/01/2012
Decision Date 03/29/2012
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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