# K992280: Lorad 1-650 (International 650)

- Pathway: 510(k) (Traditional)
- Applicant: Lorad Corp.
- Decided: Sep 3, 1999 after 58 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 K934870 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934870: Lorad D-550, Lorad Corp. (1994) Summary page 1.
- K973631: Lorad M-Iii Elite (M-Iii E), Lorad Corp. (1997) Summary page 1.

## Indications for use
The 1-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for 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/K992280
Methodology: https://510kreport.com/methodology