# K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015

- Pathway: 510(k) (Traditional)
- Applicant: Progeny, Inc.
- Decided: Dec 13, 2004 after 34 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 K935046 (1994). 2 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935046: GX-770 X-Ray Control, Model 46-404600G4, Gendex Corp. (1994) Summary page 2.
- K992610: Gendex 765DC, Model 110-0154, Dentsply Intl. (1999) Summary page 2.

## Most influential descendants
- K083344: Heliodent Plus (2008), 9 descendants of its own
- 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
- K103579: Intra Skan DC (2011), 2 descendants of its own

## Indications for use
The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.

Source page: https://510kreport.com/device/K043092
Methodology: https://510kreport.com/methodology