Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K183204 |
Device Name |
Bone VCAR (BVCAR) |
Applicant |
GE Medical Systems SCS |
283 rue de la Miniere |
buc,
FR
78530
|
|
Applicant Contact |
elizabeth matthew |
Correspondent |
GE Medical Systems SCS |
283 rue de la Miniere |
buc,
FR
78530
|
|
Correspondent Contact |
elizabeth matthew |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/19/2018 |
Decision Date | 04/08/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|