# K992037: MAMEX

- Pathway: 510(k) (Special)
- Applicant: Del Medical Imaging Corp.
- Decided: Jul 30, 1999 after 44 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The option intended to provide the operator with the capabilities of selecting Rhodium filtration for enhanced image quality.

Source page: https://510kreport.com/device/K992037
Methodology: https://510kreport.com/methodology