# K133271: Opteo, Videograph HD

- Pathway: 510(k) (Special)
- Applicant: Owandy
- Decided: Apr 28, 2014 after 186 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: 3 generations back to K950532 (1995). 4 ancestors in all.
11 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)
- K093105: Visteo, Owandy (2010) Summary page 1.

## Most influential descendants
- 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
- K202369: RXS 1000 (2021), 0 descendants of its own

## Indications for use
The Opteo 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 Opteo is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray. The dental x-ray tube (which is not part of Opteo) 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.

Source page: https://510kreport.com/device/K133271
Methodology: https://510kreport.com/methodology