# K082350: PAX-500

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 10, 2008 after 56 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: 2 generations back to K973642 (1997). 2 ancestors in all.
67 later devices descend from it; 4 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063773: Volumetric  Tomography, Instrumentarium Dental, Inc. (2007) Summary page 1.

## Most influential descendants
- K090171: Computed Tomography X-Ray System, Pax-REVE3D (2009), 59 descendants of its own
- K102259: Dental Computed Tomography X-Ray System (2011), 42 descendants of its own
- K121412: Pax-FLEX3D, PHT-7000 (2012), 28 descendants of its own
- K122606: PHT-6500; PHT-60CFO; Pax-I3D (2012), 27 descendants of its own
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (2015), 25 descendants of its own

## Indications for use
The PaX-500 is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Source page: https://510kreport.com/device/K082350
Methodology: https://510kreport.com/methodology