Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K202213 |
Device Name |
syngo.CT Neuro Perfusion |
Applicant |
Siemens Medical Solutions USA, Inc. |
2501 N. Barrington Rd. |
Hoffman Estates,
IL
60192
|
|
Applicant Contact |
Veronica Padharia |
Correspondent |
Siemens Medical Solutions USA, Inc. |
2501 N. Barrington Rd. |
Hoffman Estates,
IL
60192
|
|
Correspondent Contact |
Veronica Padharia |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 08/06/2020 |
Decision Date | 10/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|