# K132983: Ton-95LH, Pax-I3D Ortho

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Aug 7, 2014 after 318 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: 5 generations back to K973642 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102196: Computed Tomography X-Ray System, VATECH Co., Ltd. (2011) Summary page 6.

## Most influential descendants
- K160882: PaX-i3D Green Premium (Model: PCT-90LH) (2016), 0 descendants of its own

## Indications for use
PaX-i3D Ortho (TON-95LH) is a computed tomography x-ray system intended to produce cross-sectional images of the oral anatomy by reconstructing a three dimensional radiographic images from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental treatment in adult and pediatric dentistry. The system also acquires carpal images for orthodontic treatment. The device is operated and used by physicians, dentists, and x-ray technicians.

Source page: https://510kreport.com/device/K132983
Methodology: https://510kreport.com/methodology