# K161131: FONA Pan/Ceph

- Pathway: 510(k) (Traditional)
- Applicant: Fona S.R.L
- Decided: Nov 3, 2016 after 196 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: 8 generations back to K973642 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031801: Pantos, Models: Pantos 16, and Pantos DG, Blue X Imaging Srl (2003) Summary page 4.
- K150217: Orthophos SL, Sirona Dental Systems GmbH (2015) Summary page 4.

## Indications for use
The FONA Pan/Ceph device, comprising models FONA XPan DG, FONA XPan DG Plus, FONA ART Plus, and FONA ART Plus C, is an extraoral source dental X-ray system intended to perform panoramic or cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images.

Source page: https://510kreport.com/device/K161131
Methodology: https://510kreport.com/methodology