# K160882: PaX-i3D Green Premium (Model: PCT-90LH)

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 28, 2016 after 211 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: 6 generations back to K973642 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132983: Ton-95LH, Pax-I3D Ortho, VATECH Co., Ltd. (2014) Summary page 4.

## Indications for use
PaX-i3D Green Premium (Model: PCT-90LH) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental and ENT treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, ENT specialist and x-ray technicians.

Source page: https://510kreport.com/device/K160882
Methodology: https://510kreport.com/methodology