Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K192462 |
Device Name |
syngo.MR Applications |
Applicant |
Siemens Medical Solutions USA Inc. |
40 Liberty Boulevard, MailCode 65-1A |
Malvern,
PA
19355
|
|
Applicant Contact |
Cordell L. Fields |
Correspondent |
Siemens Medical Solutions USA Inc. |
40 Liberty Boulevard, MailCode 65-1A |
Malvern,
PA
19355
|
|
Correspondent Contact |
Cordell L. Fields |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/2019 |
Decision Date | 01/31/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|