# K021903: Kodak X-Omat Cassette/Leadless for Dental Use

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Jul 10, 2002 after 30 days
- Product code: IXA (Cassette, Radiographic Film)
- Device class: 2
- Regulation: 21 CFR 892.1850
- 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
KODAK X-OMAT Cassette/Leadless for Dental Use is a light-tight holder for intensifying screen and film, keeping them in close contact to provide a good radiographic image. This cassette can be used with dental x-ray imaging equipment that has an automatic exposure control (AEC) device.

Source page: https://510kreport.com/device/K021903
Methodology: https://510kreport.com/methodology