# K093105: Visteo

- Pathway: 510(k) (Abbreviated)
- Applicant: Owandy
- Decided: Oct 18, 2010 after 382 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: 2 generations back to K950532 (1995). 3 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053172: Universal-X (Usa) or /Krystal-X (Europe), Owandy Sas (2006) Summary page 1.

## Most influential descendants
- K133271: Opteo, Videograph HD (2014), 11 descendants of its own
- K151926: QuickRay HD Intraoral Sensor (2015), 10 descendants of its own
- K163282: Apex Dental Sensors (2017), 2 descendants of its own
- K162619: I View and Imagen Sensor (2016), 1 descendant of its own
- K230916: WeSensor (2023), 0 descendants of its own

## Indications for use
The VISTEO digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional X-ray tube and a Computer for dental radiographic imaging. The VISTEC is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentists wishes to X-Ray. The dental X-ray tube (which is not part of VISTEO) is pointed at the sensor and activated. The emitted radiation from the X-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

Source page: https://510kreport.com/device/K093105
Methodology: https://510kreport.com/methodology