# K170731: System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Apr 4, 2017 after 25 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K973642 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122155: PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray System, VATECH Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K240040: VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (2024), 0 descendants of its own

## Indications for use
PCH-30CS is intended to produce panoramic 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 physicians, dentists, and x-ray technicians.

Source page: https://510kreport.com/device/K170731
Methodology: https://510kreport.com/methodology