# K113284: Biopsy Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Film Medical Systems
- Decided: Mar 7, 2012 after 121 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: 4 generations back to K941191 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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
- K191495: Biopsy Positioner (2019), 0 descendants of its own

## Recalls of this device
- Jun 9, 2016 · Class II · Z-2690-2016: If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.

## Indications for use
The FUJIFILM Biopsy Positioner (FOR-i OOOBPY) is an optional accessory for the Aspire HO (FOR MS-i 000) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast 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/K113284
Methodology: https://510kreport.com/methodology