# K130419: Papaya Plus, Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Nov 6, 2013 after 260 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.
7 later devices descend from it; 1 cites it directly.
0 of 16 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 1.

## Most influential descendants
- 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
- K250060: GT300; GT300-C (2025), 0 descendants of its own
- K220423: PAPAYA & PAPAYA Plus (2022), 0 descendants of its own

## Indications for use
PAPAYA Plus is a digital extracral source X-ray system intended to produce panoramic and Cephalometric images of the oral and cranioifacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalonietric images.

Source page: https://510kreport.com/device/K130419
Methodology: https://510kreport.com/methodology