# K121236: Pax-DUO3D Plus, PCT-5000

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: May 24, 2012 after 30 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: 1 generation back to K102102 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102102: Computed Tomography X-Ray System, VATECH Co., Ltd. (2011) Summary page 3.

## Indications for use
PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dentists, dental assistants, x-ray technicians and other professionals who are licensed by the law of the State in which he or she practices to use the device.

Source page: https://510kreport.com/device/K121236
Methodology: https://510kreport.com/methodology