# K122836: Affirm Breast Biopsy Guidance System

- Pathway: 510(k) (Special)
- Applicant: Lorad, A Hologic Co.
- Decided: Jan 11, 2013 after 116 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: 4 generations back to K941191 (1995). 7 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103512: Affirm Breast Biopsy Guidance System, Hologic, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K253678: MAMMOMAT B.brilliant (11372950) (2026), 0 descendants of its own
- K210955: Kubtec Mozart Supra (XPERT 84) Radiography System (2021), 0 descendants of its own

## Indications for use
The Affirm breast biopsy guidance system is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Source page: https://510kreport.com/device/K122836
Methodology: https://510kreport.com/methodology