# K130585: PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Jul 15, 2013 after 132 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.
No later device cites it as a predicate yet.
0 of 9 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 7.

## Indications for use
PCH-2500 is a digital extra oral source X-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and X-ray technicians and other professionals licensed by the law of the states in which the device is used.

Source page: https://510kreport.com/device/K130585
Methodology: https://510kreport.com/methodology