# K023020: Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Sep 26, 2002 after 15 days
- Product code: IXA (Cassette, Radiographic Film)
- Device class: 2
- Regulation: 21 CFR 892.1850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790273 (1979). 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)
- K790273: Mammography System and Cassette, Agfa-Gevaert, Inc. (1979) Summary page 1.
- K890750: Kodak X-Omatic RA Cassette, Eastman Kodak Company (1989) Summary page 1.

## Recalls of this device
- Jan 26, 2005 · Not classified · Z-1404-05: Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.

## Indications for use
The Agfa Film Cassettes are indicated for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a lightproof enclosure for direct exposure of radiographic film.

Source page: https://510kreport.com/device/K023020
Methodology: https://510kreport.com/methodology