Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K133654 |
Device Name |
SCENIUM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
2501 NORTH BARRINGTON RD. |
HOFFMAN ESTATES,
IL
60192
|
|
Applicant Contact |
MARIA EBIO |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
2501 NORTH BARRINGTON RD. |
HOFFMAN ESTATES,
IL
60192
|
|
Correspondent Contact |
MARIA EBIO |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/27/2013 |
Decision Date | 02/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|