# K092591: Orthopantomograph OP30

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Dental, Palodex Group OY
- Decided: Nov 20, 2009 after 88 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
Longest line of descent: 4 generations back to K972312 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063459: Cranex Novus, Soredex Palodex Group OY (2006) Summary page 1.

## Indications for use
The Orthopantomograph® OP30 dental panoramic x-ray equipment is intended for dental radiographic examinations by producing digital radiographs of teeth, TM-joints and other oral structures by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K092591
Methodology: https://510kreport.com/methodology