# K964576: Profile Mammography System (M-Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Bennett X-Ray Corp.
- Decided: Jan 10, 1997 after 57 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 K925725 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925725: Contour Mammography System, Model Number M-CTR, Bennett X-Ray Corp. (1993) Summary page 1.

## Most influential descendants
- K984092: Profile 2000 Mammography System, Pro-2000 (1999), 0 descendants of its own

## Indications for use
The Bennett Profile mammography system, like the Bennett Contour M-CTR, LORAD M-1V, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.

Source page: https://510kreport.com/device/K964576
Methodology: https://510kreport.com/methodology