TOSHIBA 3T 32CH HEAD SPEEDER COIL,


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

Correspodent Contact kathleen aras
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 08/29/2012
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