# K000976: Diamond (Mammographic X-Ray System)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Imaging, Inc.
- Decided: Jun 1, 2000 after 66 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K022275: Delta 32; Delta 32 Tact (2002), 0 descendants of its own

## Recalls of this device
- Nov 16, 2005 · Not classified · Z-0976-2007: GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety.

Source page: https://510kreport.com/device/K000976
Methodology: https://510kreport.com/methodology