# K024186: X-VIEW

- Pathway: 510(k) (Traditional)
- Applicant: Sometech Corporation
- Decided: Apr 1, 2004 after 469 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 K923067 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962337: Elitys or Elitys-E, Trophy Radiologie (1996) Summary page 2.
- K923067: Sens-a-Ray, Regam Medical Systems (1992) Summary page 2.

## Indications for use
The X - VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.

Source page: https://510kreport.com/device/K024186
Methodology: https://510kreport.com/methodology