Device Classification Name |
system, x-ray, mammographic
|
510(k) Number |
K113284 |
Device Name |
BIOPSY POSITIONER |
Applicant |
FUJI FILM MEDICAL SYSTEMS |
419 WEST AVE. |
STAMFORD,
CT
06902
|
|
Applicant Contact |
KIMERLY A SHARP |
Correspondent |
FUJI FILM MEDICAL SYSTEMS |
419 WEST AVE. |
STAMFORD,
CT
06902
|
|
Correspondent Contact |
KIMERLY A SHARP |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 11/07/2011 |
Decision Date | 03/07/2012 |
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
|
|
|