# K210329: Green X 18(Model : PHT-75CHS)

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: Feb 18, 2021 after 14 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: 11 generations back to K973642 (1997). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201627: Dental Computed Tomography X-Ray System, Green X, VATECH Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K243081: Green X 21  (PHT-90CHO) (2025), 1 descendant of its own
- K260093: Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (2026), 0 descendants of its own

## Indications for use
Green X 18 (Model : PHT-75CHS) is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.

Source page: https://510kreport.com/device/K210329
Methodology: https://510kreport.com/methodology