Device Classification Name |
system, x-ray, mammographic
|
510(k) Number |
K122836 |
Device Name |
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
Applicant |
LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. |
DANBURY,
CT
06810
|
|
Applicant Contact |
GAIL YAEKER-DAUNIS |
Correspondent |
LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. |
DANBURY,
CT
06810
|
|
Correspondent Contact |
GAIL YAEKER-DAUNIS |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 09/17/2012 |
Decision Date | 01/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|