Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K173611 |
Device Name |
syngo Application Software |
Applicant |
Siemens Medical Solutions, USA Inc. |
40 Liberty Boulevard |
65-1A |
Malvern,
PA
19355
|
|
Applicant Contact |
Patricia D. Jones |
Correspondent |
Siemens Medical Solutions, USA Inc. |
40 Liberty Boulevard |
65-1A |
Malvern,
PA
19355
|
|
Correspondent Contact |
Patricia D. Jones |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/22/2017 |
Decision Date | 03/16/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|