# K120318: Vivi Ergon-X HF

- Pathway: 510(k) (Traditional)
- Applicant: Vivi S.R.L.
- Decided: Mar 6, 2012 after 33 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: 3 generations back to K935046 (1994). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083344: Heliodent Plus, Sirona Dental Systems GmbH (2008) Summary page 1.
- K030634: Endos DC, Villa Sistemi Medicali S.P.A. (2003) Summary page 1.
- K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015, Progeny, Inc. (2004) Summary page 1.

## 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
- K130109: Endograph DC (2013), 1 descendant of its own
- K231055: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) (2023), 0 descendants of its own

## Indications for use
Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.

Source page: https://510kreport.com/device/K120318
Methodology: https://510kreport.com/methodology