# K163519: RX DC

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Jan 13, 2017 after 29 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: 4 generations back to K935046 (1994). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080076: RX DC X-Ray Unit, Cefla S.C.R.L. (2008) Summary page 5.
- K120318: Vivi Ergon-X HF, Vivi S.R.L. (2012) Summary page 5.

## Most influential descendants
- 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
RX DC 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/K163519
Methodology: https://510kreport.com/methodology