# K232085: Dvas (Dvas-M, Dvas-W)

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Dec 8, 2023 after 148 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
Longest line of descent: 6 generations back to K935046 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182206: RiX70 DC, Trident S.R.L (2018) Summary page 5.

## Indications for use
DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.

Source page: https://510kreport.com/device/K232085
Methodology: https://510kreport.com/methodology