GENORAY AMERICA INC.

FDA Device Registration & Listing · Anaheim, CA, US · Registration 3007538876

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007538876
FEI Number
3007538876
Entity Name
GENORAY AMERICA INC.
City/State/Country
Anaheim, CA, US
Establishment Address
1220 N Simon Circle, Unit B, Anaheim, CA 92806, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
Genoray America Inc. (Owner Number: 10029239)
Owner / Operator Contact Address
1220 N Simon Circle, Unit B, Anaheim, CA 92806, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K150354
PMA Number
N/A

All Registered Proprietary Names

PAPAYA Plus PAPAYA Plus PAPAYA 3D Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2016-01-21
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2013-11-12
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2016-01-21
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2016-01-21

Official Correspondent

Nate Keum

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Genoray America Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22
K160788 Ray Co., Ltd. RIOScan (RPS500) 2016-04-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007538876. Last updated year: 2026. Please use registration number 3007538876 when referencing this establishment in official correspondence.
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