# K053172: Universal-X (Usa) or /Krystal-X (Europe)

- Pathway: 510(k) (Traditional)
- Applicant: Owandy Sas
- Decided: Jun 9, 2006 after 207 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: 1 generation back to K950532 (1995). 2 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950532: Trophy Radiologie RVG Portable Radiovisiography, Trophy Radiologie (1995) Summary page 2.
- K031448: RSV (Radiology System Visiodent, Visiodent SA (2003) Summary page 2.

## Most influential descendants
- K070505: Krystal-X Wifi (2007), 44 descendants of its own
- K081722: YSIO (2008), 43 descendants of its own
- K121513: Multix Fusion (2012), 32 descendants of its own
- K133259: Ysio Max (2014), 23 descendants of its own
- K142049: Multix Fusion VA30 & VA40 (2014), 18 descendants of its own

## Indications for use
The UNLVERSAL-X 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 Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray. The dental X-ray tube (which is not part of Universal-X) 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. Similar devices have been in use in the USA since 1989, and are now well accepted by dentists.

Source page: https://510kreport.com/device/K053172
Methodology: https://510kreport.com/methodology