# K062039: Biopsy Digit-AM

- Pathway: 510(k) (Traditional)
- Applicant: Giotto USA, LLC
- Decided: Sep 11, 2006 after 54 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: 2 generations back to K923061 (1992). 2 ancestors in all.
2 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)
- K990192: Biopsy-Digit, Sitco, Inc. (1999) Summary page 1.

## Most influential descendants
- 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 Biopsy Digit-AM is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy, and guide wire placement.

Source page: https://510kreport.com/device/K062039
Methodology: https://510kreport.com/methodology