# K220423: PAPAYA & PAPAYA Plus

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: May 19, 2022 after 94 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: 9 generations back to K973642 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141700: Papaya Plus, Digital Extraoral Source X-Ray System, Genoray Co., Ltd. (2014) Summary page 4.

## Indications for use
PAPAYA & PAPAYA Plus are digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial 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 cephalometric images. And This system can be equipped cust(Tomographic) option, which is capable of taking cross-sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted tecth.

Source page: https://510kreport.com/device/K220423
Methodology: https://510kreport.com/methodology