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 Number | 892.1000
|
Classification Product Code |
|
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
|
|
|