# K990192: Biopsy-Digit

- Pathway: 510(k) (Traditional)
- Applicant: Sitco, Inc.
- Decided: Mar 12, 1999 after 50 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: 1 generation back to K923061 (1992). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923061: Mammoscan, Fischer Imaging Corp. (1992) Summary page 1.

## Most influential descendants
- K062039: Biopsy Digit-AM (2006), 2 descendants of its own
- K113607: Biopsy Digit S Biopsy SL (2012), 1 descendant of its own
- K163388: XPress BCD Breast Compression Device (2017), 0 descendants of its own

## Indications for use
The intended uses of the Biopsy Digit are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

Source page: https://510kreport.com/device/K990192
Methodology: https://510kreport.com/methodology