# K070505: Krystal-X Wifi

- Pathway: 510(k) (Traditional)
- Applicant: Owandy
- Decided: Apr 5, 2007 after 43 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: 2 generations back to K933455 (1994). 6 ancestors in all.
44 later devices descend from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050693: Accent, Air Techniques, Inc. (2005) Summary page 1.
- K022953: Modification to Computed Oral Radiology System, Schick Technologies, Inc. (2002) Summary page 1.
- K053172: Universal-X (Usa) or /Krystal-X (Europe), Owandy Sas (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K061114: WDS, Size 2 and Size 2, Cefla S.C.R.L. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K162971: Multix Fusion Max (2016), 10 descendants of its own

## Indications for use
The KRYSTAL-X WiFI digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFI), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-ray dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.

Source page: https://510kreport.com/device/K070505
Methodology: https://510kreport.com/methodology