Device Classification Name |
Lung Computed Tomography System, Computer-Aided Detection
|
510(k) Number |
K203258 |
Device Name |
syngo.CT Lung CAD |
Applicant |
Siemens Healthcare GmbH |
Siemensstr. 1 |
Forchheim,
DE
91301
|
|
Applicant Contact |
Abhineet Johri |
Correspondent |
Siemens Healthcare GmbH |
Siemensstr. 1 |
Forchheim,
DE
91301
|
|
Correspondent Contact |
Abhineet Johri |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/05/2020 |
Decision Date | 03/31/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|