# K921962: Lorad Digital Spot Mammography

- Pathway: 510(k) (Traditional)
- Applicant: Lorad Medical Systems, Inc.
- Decided: Nov 23, 1992 after 210 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040884: Lorad Digital Spot Mammography System (2004), 15 descendants of its own
- 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

Source page: https://510kreport.com/device/K921962
Methodology: https://510kreport.com/methodology