# K033755: Minray

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Apr 29, 2004 after 150 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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
Longest line of descent: 1 generation back to K960819 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960819: Heliodent DS, Pelton & Crane Co. (1996) Summary page 1.

## Indications for use
The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.

Source page: https://510kreport.com/device/K033755
Methodology: https://510kreport.com/methodology