Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K143319 |
Device Name |
Syngo X-workplace SW VD10 |
Applicant |
Siemens Medical Solutions, Inc |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Patricia D. Jones |
Correspondent |
Siemens Medical Solutions, Inc |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
Patricia D. Jones |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/19/2014 |
Decision Date | 02/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|