# K102124: Dental Computed Tomography X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 22, 2010 after 85 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: 4 generations back to K973642 (1997). 5 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090171: Computed Tomography X-Ray System, Pax-REVE3D, E-Woo Technology (2009) Summary page 2.

## Most influential descendants
- K120263: Volux 21C, Digital Extraoral Source X-Ray System (2012), 14 descendants of its own
- K123070: Galileos Family (2013), 13 descendants of its own
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System (2014), 6 descendants of its own
- K150217: Orthophos SL (2015), 5 descendants of its own
- K162085: i-CAT FLX V series / KaVo 3D eXam+ V series (2016), 2 descendants of its own

## Indications for use
PaX-Reve3D Plus is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and craniofacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 3600 rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care The device is operated and used by physicians, dentists, and x-ray technicians.

Source page: https://510kreport.com/device/K102124
Methodology: https://510kreport.com/methodology