Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K192061 |
Device Name |
SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO |
Applicant |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Applicant Contact |
Alaine Medio |
Correspondent |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Correspondent Contact |
Alaine Medio |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 08/01/2019 |
Decision Date | 11/21/2019 |
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
|
|
|