# K080889: Kodak 9000C Extraoral Imaging System

- Pathway: 510(k) (Special)
- Applicant: Trophy
- Decided: Apr 29, 2008 after 29 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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 9000C digital dental panoramic and cephalometric X-ray system is to be used as an extraoral source of X-rays for imaging of the dento-maxillo-facial area.

Source page: https://510kreport.com/device/K080889
Methodology: https://510kreport.com/methodology