# K080076: RX DC X-Ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.R.L.
- Decided: Mar 14, 2008 after 63 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K163519: RX DC (2017), 4 descendants of its own
- K182206: RiX70 DC (2018), 3 descendants of its own
- K211014: Portray (2021), 1 descendant of its own
- K232085: Dvas (Dvas-M, Dvas-W) (2023), 0 descendants of its own
- K223780: Lumos 3DX (2023), 0 descendants of its own

## Indications for use
This x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.

Source page: https://510kreport.com/device/K080076
Methodology: https://510kreport.com/methodology