# K222666: X-View 3D Pan/X-View 2D Pan

- Pathway: 510(k) (Traditional)
- Applicant: Trident S.R.L
- Decided: Jul 10, 2023 after 307 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K973598 (1997). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160166: X-MIND trium, De Gotzen S.R.L. (2016) Summary page 4.
- K182198: Panoura X-ERA PF/NF/MF, The Yoshida Dental Mfg. Co., Ltd. (2019) Summary page 5.

## Indications for use
The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years. The device must only be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K222666
Methodology: https://510kreport.com/methodology