# K243088: Green X 12 SE  (PHT-40CHS)

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: Feb 21, 2025 after 144 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: 12 generations back to K973642 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231796: Grreen X 12 (Model: PHT-75CHS), VATECH Co., Ltd. (2023) Summary page 5.

## Indications for use
Green X 12 (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, 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/K243088
Methodology: https://510kreport.com/methodology