# K122155: PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Special)
- Applicant: VATECH Co., Ltd.
- Decided: Sep 4, 2012 after 46 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: 6 generations back to K973642 (1997). 7 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113672: PCH-2500 Digital Extraoral Source X-Ray System, VATECH Co., Ltd. (2012)

## Most influential descendants
- K130419: Papaya Plus, Digital Extraoral Source X-Ray System (2013), 7 descendants of its own
- K141700: Papaya Plus, Digital Extraoral Source X-Ray System (2014), 6 descendants of its own
- K150354: PAPAYA 3D Plus (2015), 4 descendants of its own
- K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus (2020), 1 descendant of its own
- K170731: System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight (2017), 1 descendant of its own

## Indications for use
PCH-2500 (PaX-i) 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 state in which the device is used.

Source page: https://510kreport.com/device/K122155
Methodology: https://510kreport.com/methodology