# K170066: Green16/Green18 (Model: PHT-65LHS)

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Jun 16, 2017 after 158 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: 9 generations back to K973642 (1997). 10 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162660: Green Smart (Model: PHT-35LHS), VATECH Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K181452: RCT800 (2018), 10 descendants of its own
- K182805: RCT800 (2018), 8 descendants of its own
- K192737: RCT800 (2019), 7 descendants of its own
- K182614: RCT700 (2018), 6 descendants of its own
- K213226: RCT700 (2021), 5 descendants of its own

## Indications for use
PHT-65LHS 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/K170066
Methodology: https://510kreport.com/methodology