# K231055: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

- Pathway: 510(k) (Abbreviated)
- Applicant: De Götzen S.R.L.
- Decided: Dec 28, 2023 after 259 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: 5 generations back to K935046 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130109: Endograph DC, Villa Sistemi Medicali S.P.A. (2013) Summary page 4.

## Indications for use
x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital x-ray sensors) that are not part of the device. The device is operated and used by dentists, radiologists and other legally qualified health care professionals.

Source page: https://510kreport.com/device/K231055
Methodology: https://510kreport.com/methodology