Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K142515 |
Device Name |
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra |
Applicant |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway, Mailcode D02 |
Malvern,
PA
19355
|
|
Applicant Contact |
Cordell L. Fields |
Correspondent |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway, Mailcode D02 |
Malvern,
PA
19355
|
|
Correspondent Contact |
Cordell L. Fields |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 09/08/2014 |
Decision Date | 10/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|