# K153486: Affirm Prone Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Apr 1, 2016 after 119 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: 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)
- K030666: Multicare Platinum System and Accessories, Lorad, A Hologic Co. (2003) Summary page 4.
- K122836: Affirm Breast Biopsy Guidance System, Lorad, A Hologic Co. (2013) Summary page 4.

## Indications for use
The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.

Source page: https://510kreport.com/device/K153486
Methodology: https://510kreport.com/methodology