Registered with FDA

Genoray America Inc.

Anaheim, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator10029239Repacker / relabeler

Device types listed: 2
Brands and models: 3
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1United States

Devices listed with FDA

What Genoray America Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Digital Extraoral Source X-Ray SystemMUH · Class 2	Dental X-ray units	Lister	PAPAYA 3D PlusPAPAYA Plus	2013
Dental Computed Tomography X-RayOAS · Class 2	Dental CBCT	Lister	PAPAYA 3D Plus	2016

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Genoray America Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Genoray Co., Ltd. (3).

Decided	510(k)	Device	Applicant	Device type
10 Dec 2015	K150354	PAPAYA 3D Plus	Genoray Co., Ltd.	OAS Dental Computed Tomography X-Ray
31 Oct 2014	K141700	PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Genoray Co., Ltd.	MUH Digital Extraoral Source X-Ray System
6 Nov 2013	K130419	PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Genoray Co., Ltd.	MUH Digital Extraoral Source X-Ray System

Registered establishments

Establishment	Location	What it does
GENORAY AMERICA INC.FDA reg. 3007538876	Anaheim, CA, United States	Complaint file establishment, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10029239). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.