# K141700: Papaya Plus, Digital Extraoral Source X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Oct 31, 2014 after 129 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: 8 generations back to K973642 (1997). 12 ancestors in all.
6 later devices descend from it; 2 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)
- K130419: Papaya Plus, Digital Extraoral Source X-Ray System, Genoray Co., Ltd. (2013) Summary page 4.
- K063773: Volumetric  Tomography, Instrumentarium Dental, Inc. (2007) Summary page 4.
- K043612: Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D, Instrumentarium Corp. Imaging Division (2005). Our reading of the summary gave K046312, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Orthopantomograph OP 200”.

## Most influential descendants
- 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
- K220392: PAPAYA 3D & PAPAYA 3D Plus (2022), 0 descendants of its own

## Indications for use
PAPAYA Plus is a 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 teeth.

Source page: https://510kreport.com/device/K141700
Methodology: https://510kreport.com/methodology