AFFIRM BREAST BIOPSY GUIDANCE SYSTEM


Device Classification Name

system, x-ray, mammographic

510(k) Number K103512
Device Name AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Applicant
HOLOGIC, INC.
36 apple ridge road
danbury, 
CT 
06810

Applicant Contact gail yaeker-dauni
Correspondent
HOLOGIC, INC.
36 apple ridge road
danbury, 
CT 
06810

Correspodent Contact gail yaeker-dauni
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 11/30/2010
Decision Date 01/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No