Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K222360 |
Device Name |
AI-Rad Companion (Cardiovascular) |
Applicant |
Siemens Medical Solutions U.S.A. |
40 Liberty Blvd. |
Malvern,
PA
19355
|
|
Applicant Contact |
Alexandra Fink |
Correspondent |
Siemens Medical Solutions U.S.A. |
40 Liberty Blvd. |
Malvern,
PA
19355
|
|
Correspondent Contact |
Alexandra Fink |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/04/2022 |
Decision Date | 04/06/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|