Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K121074 |
FOIA Releasable 510(k) |
K121074
|
Device Name |
SCENIUM 2.0 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
810 INNOVATION DR. |
KNOXVILLE,
TN
37932
|
|
Applicant Contact |
ELAINE CHANG |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
810 INNOVATION DR. |
KNOXVILLE,
TN
37932
|
|
Correspondent Contact |
ELAINE CHANG |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2012 |
Decision Date | 06/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|