# K150354: PAPAYA 3D Plus

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Dec 10, 2015 after 302 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: 9 generations back to K973642 (1997). 14 ancestors in all.
4 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)
- K123381: Hyperion X9, Cefla S.C. (2013) Summary page 4.
- K141700: Papaya Plus, Digital Extraoral Source X-Ray System, Genoray Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus (2020), 1 descendant of its own
- K250060: GT300; GT300-C (2025), 0 descendants of its own
- K220392: PAPAYA 3D & PAPAYA 3D Plus (2022), 0 descendants of its own
- K151137: X-View, Imagen (2016), 0 descendants of its own

## Indications for use
PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing twodimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

Source page: https://510kreport.com/device/K150354
Methodology: https://510kreport.com/methodology