Device Classification Name |
full field digital, system, x-ray, mammographic
|
510(k) Number |
K162268 |
Device Name |
Senographe Pristina |
Applicant |
GE HEALTHCARE |
283 RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Applicant Contact |
Gregory Pessato |
Correspondent |
GE HEALTHCARE |
283 RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Correspondent Contact |
Gregory Pessato |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 08/12/2016 |
Decision Date | 11/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|