# K203797: vatech A9 (Model : PHT-30CSS)

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: Jan 25, 2021 after 28 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.
No later device cites it as a predicate yet.
0 of 12 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.

## Indications for use
vatech A9 (PHT-30CSS) is intended to produce panoramic, cone beam computed tomography, or cephalometric 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/K203797
Methodology: https://510kreport.com/methodology