# K222274: Fona XDC

- Pathway: 510(k) (Special)
- Applicant: Fona S.R.L
- Decided: Aug 23, 2022 after 25 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 K031118 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031118: Intraos 70, Blue X Imaging Srl (2003) Summary page 4.

## Indications for use
FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.

Source page: https://510kreport.com/device/K222274
Methodology: https://510kreport.com/methodology