# K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Sep 16, 2020 after 203 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K973642 (1997). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150354: PAPAYA 3D Plus, Genoray Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K250060: GT300; GT300-C (2025), 0 descendants of its own

## Indications for use
The X-ray unit system is a diagnostic imaging system which consists of multiple image acquisition modes; panoramic, cephalometric, and CBCT (Cone Beam Computed Tomography). X-ray unit system is used for dental radiographic examination and diagnosis of teeth, jaw, oral structures and skull. The device is to be operated and used dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K200469
Methodology: https://510kreport.com/methodology