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Papaya Plus, Digital Extraoral Source X-Ray System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141700

by Genoray Co., Ltd.

Identifiers

510(k) Number
K141700 FDA 510(k)
FDA Product Code
MUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth.

This generic type of device may include patient and equipment supports and component parts. 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. It is authorized under FDA 510(k) clearance K141700 and is classified as a Class II medical device.

Frequently asked questions

What is the Papaya Plus digital extraoral source X-ray system intended for?

The Papaya Plus system is an AC-powered extraoral source X-ray device intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures, as well as skull radiographic examination, by exposing an X-ray image receptor to ionizing radiation with the X-ray tube located outside the mouth.

How is the Papaya Plus system supplied and what is its regulatory authorization?

The Papaya Plus system is supplied as a complete extraoral source X-ray system including the X-ray tube, patient and equipment supports, and component parts. It received FDA 510(k) clearance under K141700 on October 31, 2014, and is classified as a Class II medical device under product code MUH and regulation number 872.1800.

What type of clearance did the Papaya Plus system receive and what does it indicate?

The Papaya Plus system received a traditional 510(k) clearance with a decision of substantially equivalent (SESE), indicating it was found to be substantially equivalent to a legally marketed predicate device. This clearance pathway is used for devices that demonstrate similarity to existing legally marketed devices in terms of intended use and technological characteristics.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Papaya Plus, Digital Extraoral Source X-ray System (K130419) — Fda 510 ..., Papaya Plus, Digital Extraoral Source X-ray System (K141700) — Fda 510 ..., GENORAY

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genoray Co., Ltd.

Sources (1)

  • FDA 510(k) K141700 24 fields · synced Sep 19, 2026