# K161575: Affirm Lateral Arm Upright Biopsy Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Hologic
- Decided: Aug 10, 2016 after 64 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941191 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122836: Affirm Breast Biopsy Guidance System, Lorad, A Hologic Co. (2013) Summary page 4.
- K040125: Senographic Stereo, Ge Medical Systems, Inc. (2004) Summary page 4.

## Recalls of this device
- Jul 7, 2017 · Class II · Z-0351-2018: The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blu

## 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/K161575
Methodology: https://510kreport.com/methodology