Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K191891 |
Device Name |
SOMATOM X.cite |
Applicant |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Applicant Contact |
Tabitha Estes |
Correspondent |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Correspondent Contact |
Tabitha Estes |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/15/2019 |
Decision Date | 11/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|