# K201627: Dental Computed Tomography X-Ray System, Green X

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 27, 2020 after 133 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: 10 generations back to K973642 (1997). 11 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170066: Green16/Green18 (Model: PHT-65LHS), VATECH Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K231796: Grreen X 12 (Model: PHT-75CHS) (2023), 2 descendants of its own
- K210329: Green X 18(Model : PHT-75CHS) (2021), 2 descendants of its own
- 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
- K243088: Green X 12 SE  (PHT-40CHS) (2025), 0 descendants of its own

## Indications for use
Green X (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/K201627
Methodology: https://510kreport.com/methodology