Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K151353 |
Device Name |
syngo.MR Neurology, syngo.MR Oncology |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY |
MAVERN,
PA
19355
|
|
Applicant Contact |
CORDELL L. FIELDS |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY |
MAVERN,
PA
19355
|
|
Correspondent Contact |
CORDELL L. FIELDS |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/20/2015 |
Decision Date | 08/07/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|