# K960381: Mam-CH22S with Automatic Filter Selection Option

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Apr 29, 1996 after 94 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 K941353 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941353: Mam-CH22S Mammography System with Optional Mammoguide Steriotactic Biopsy System, Elscint, Inc. (1995) Summary page 1.

## Most influential descendants
- K970680: GLORY (1997), 1 descendant of its own
- K983313: Advanced Automatic Detector Selection Option for Glory (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K960381
Methodology: https://510kreport.com/methodology