# K100692: Digital Spot Mammography System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Apr 6, 2010 after 27 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

Source page: https://510kreport.com/device/K100692
Methodology: https://510kreport.com/methodology