# K983313: Advanced Automatic Detector Selection Option for Glory

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Dec 11, 1998 after 81 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: 3 generations back to K941353 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970680: GLORY, Elscint, Inc. (1997) Summary page 1.

## Indications for use
Radiography of the breast Preoperative wire localization and stereotactic biopsy procedures

Source page: https://510kreport.com/device/K983313
Methodology: https://510kreport.com/methodology