# K103512: Affirm Breast Biopsy Guidance System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Jan 7, 2011 after 38 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941191 (1995). 6 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071542: Digital Stereoloc II, Lorad, A Hologic Co. (2007) Summary page 1.

## Most influential descendants
- K122836: Affirm Breast Biopsy Guidance System (2013), 9 descendants of its own
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own
- K233539: MAMMOMAT B.brilliant (2024), 1 descendant of its own
- K113284: Biopsy Positioner (2012), 1 descendant of its own

## Indications for use
The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Source page: https://510kreport.com/device/K103512
Methodology: https://510kreport.com/methodology