Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K130749 |
Device Name |
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355
|
|
Applicant Contact |
NADIA SOOKDEO |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355
|
|
Correspondent Contact |
NADIA SOOKDEO |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/19/2013 |
Decision Date | 08/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|