# K113672: PCH-2500 Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Mar 27, 2012 after 105 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: 5 generations back to K973642 (1997). 6 ancestors in all.
12 later devices descend from it; 1 cites 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)
- K102259: Dental Computed Tomography X-Ray System, VATECH Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K122155: PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray System (2012), 11 descendants of its own
- 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

## Indications for use
PCH-2500 is 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/K113672
Methodology: https://510kreport.com/methodology