# K031448: RSV (Radiology System Visiodent

- Pathway: 510(k) (Traditional)
- Applicant: Visiodent SA
- Decided: Jul 31, 2003 after 85 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
No predicates in its family tree.
66 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053172: Universal-X (Usa) or /Krystal-X (Europe) (2006), 58 descendants of its own
- 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

## Indications for use
The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient’s mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays. RSV is therefore similar to Trophy’s RVG and Video Dental Concept’s QuickRay and several other legal systems, in its intended use.

Source page: https://510kreport.com/device/K031448
Methodology: https://510kreport.com/methodology