# K030634: Endos DC

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Jul 21, 2003 after 144 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: 1 generation back to K992610 (1999). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992610: Gendex 765DC, Model 110-0154, Dentsply Intl. (1999). Our reading of the summary gave K092610, FDA’s number for Modification to Beacon Stabilization System (Globus Medical, Inc.), decided Sep 24, 2009, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GENDEX DENTSPLY model 765DC”.

## Most influential descendants
- K120318: Vivi Ergon-X HF (2012), 7 descendants of its own
- 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

## Indications for use
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

Source page: https://510kreport.com/device/K030634
Methodology: https://510kreport.com/methodology