# K980581: Planmeca Dixi, Digital Intraoral X-Ray Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Apr 17, 1998 after 59 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
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
The Planmeca Dixi is a Digital Intraoral X-ray Imaging System, which is an accessory to Intraoral X-ray devices, i.e. extraoral source x-ray systems with intraoral image receptors. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The Dixi is using intraoral x-ray sensor technique, with images displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

Source page: https://510kreport.com/device/K980581
Methodology: https://510kreport.com/methodology