# K982049: Biopsy M

- Pathway: 510(k) (Traditional)
- Applicant: Sitco, Inc.
- Decided: Jul 14, 1998 after 33 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 K933430 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933430: Cytoguide Stereotatic Biopsy System, Gold Coast Imaging, Inc. (1994) Summary page 1.

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

Source page: https://510kreport.com/device/K982049
Methodology: https://510kreport.com/methodology