# K191495: Biopsy Positioner

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Jul 3, 2019 after 28 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)
- K113284: Biopsy Positioner, Fuji Film Medical Systems (2012) Summary page 4.

## Indications for use
The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) 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 and/or Digital Breast Tomosynthesis (DBT) 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/K191495
Methodology: https://510kreport.com/methodology