Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K140253 |
Device Name |
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY, MAILCODE D02 |
MALVERN,
PA
19355
|
|
Applicant Contact |
CORDELL FIELDS |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY, MAILCODE D02 |
MALVERN,
PA
19355
|
|
Correspondent Contact |
CORDELL FIELDS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/31/2014 |
Decision Date | 03/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|