Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K211180 |
Device Name |
Liver Suite |
Applicant |
GE Medical Systems SCS |
283, rue de la Miniere |
BUC,
FR
78530
|
|
Applicant Contact |
Peter Uhlir |
Correspondent |
GE Medical Systems SCS |
283, rue de la Miniere |
BUC,
FR
78530
|
|
Correspondent Contact |
Peter Uhlir |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/20/2021 |
Decision Date | 05/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|