# K973631: Lorad M-Iii Elite (M-Iii E)

- Pathway: 510(k) (Traditional)
- Applicant: Lorad Corp.
- Decided: Dec 23, 1997 after 90 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.
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. The FDA summary names its predicate without a number.
- (no number) Lorad M-II Mammographic X-ray System: named in the summary without a submission number
- (no number) Lorad M-IV Mammographic X-ray System: named in the summary without a submission number

## Most influential descendants
- K992280: Lorad 1-650 (International 650) (1999), 0 descendants of its own

## Indications for use
The Lorad M-IIIe Mammography System is intended to produce radiographic images of the breast. Its specific intended use is screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.

Source page: https://510kreport.com/device/K973631
Methodology: https://510kreport.com/methodology