Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K100619 |
Device Name |
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA INC. |
2501 NORTH BARRINGTON ROAD |
HOFFMAN ESTATES,
IL
60192
|
|
Applicant Contact |
ELAINE CHANG |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA INC. |
2501 NORTH BARRINGTON ROAD |
HOFFMAN ESTATES,
IL
60192
|
|
Correspondent Contact |
ELAINE CHANG |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/04/2010 |
Decision Date | 05/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|