# K061114: WDS, Size 2 and Size 2

- Pathway: 510(k) (Abbreviated)
- Applicant: Cefla S.C.R.L.
- Decided: Jun 6, 2006 after 46 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 K990002 (1999). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031448: RSV (Radiology System Visiodent, Visiodent SA (2003) Summary page 1.
- K050693: Accent, Air Techniques, Inc. (2005) Summary page 1.
- K990002: Quickray DSX 730, Julie Alliance (1999) Summary page 1.

## Most influential descendants
- K080738: Dentron Sensor (2008), 3 descendants of its own
- K092537: Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 (2009), 2 descendants of its own
- K110886: Clio/Cliosoft (2011), 1 descendant of its own
- K241495: Jazz Classic (2024), 0 descendants of its own
- K100960: WDS X-Pod and Zen-X Digital X-Ray Sensors (2010), 0 descendants of its own

## Indications for use
the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes. The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.

Source page: https://510kreport.com/device/K061114
Methodology: https://510kreport.com/methodology