# K040884: Lorad Digital Spot Mammography System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Apr 23, 2004 after 18 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 K921962 (1992). 2 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921962: Lorad Digital Spot Mammography, Lorad Medical Systems, Inc. (1992) Summary page 1.
- K030666: Multicare Platinum System and Accessories, Lorad, A Hologic Co. (2003) Summary page 1.

## Most influential descendants
- K071542: Digital Stereoloc II (2007), 14 descendants of its own
- K103512: Affirm Breast Biopsy Guidance System (2011), 13 descendants of its own
- K122836: Affirm Breast Biopsy Guidance System (2013), 9 descendants of its own
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own

## Indications for use
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/K040884
Methodology: https://510kreport.com/methodology