# K102196: Computed Tomography X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Mar 25, 2011 after 239 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: 4 generations back to K973642 (1997). 5 ancestors in all.
2 later devices descend 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)
- K090991: Computed Tomography X-Ray System, Model Picasso-Duo, E-Woo Technology (2009) Summary page 2.

## Most influential descendants
- K132983: Ton-95LH, Pax-I3D Ortho (2014), 1 descendant of its own
- K160882: PaX-i3D Green Premium (Model: PCT-90LH) (2016), 0 descendants of its own

## Indications for use
PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.

Source page: https://510kreport.com/device/K102196
Methodology: https://510kreport.com/methodology