Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005843418

FEI Number

3005843418

Entity Name

GENORAY CO., LTD.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

60, Dunchon-daero 541beon-gil, Jungwon-gu, Seongnam-si Gyeonggi 13212, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GENORAY CO., LTD. (Owner Number: 9093488)

Owner / Operator Contact Address

60, Dunchon-daero 541beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi, 13212, KOREA, SOUTH, SEONGNAM, KR-NOTA 13212, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200469

PMA Number

N/A

All Registered Proprietary Names

PAPAYA 3D Plus PAPAYA 3D ZEN-7000 GT300 GT300-C PAPAYA Plus PAPAYA PortView HESTIA AREX VETERA ACE BELLIGER ACE GenX-CR ZEN-PX2 PORT-X II OSCAR 15 ZEN-2090 Turbo VETERA TURBO VETERA PX VETERA PE ZEN-PX4 Vet PORT-X Ive Vet ZEN-PX4 PORT-X IV ZEN-PX4e Vet PORT-X IV Vet PAPAYA 3D Premium Plus PAPAYA 3D Premium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2022-05-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-12-01
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2014-12-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-12-01
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2025-11-18
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2025-11-18
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2022-05-19
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2013-07-22
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-07-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2026-04-07
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-04-07
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-09-20
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2007-04-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-04-02
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-04-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-03-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-03-15
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2022-03-15
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2018-04-02
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-10-13
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2020-10-13

Official Correspondent

No official correspondent registered.

US Agent Details

Jo Suyoung Business: Simon Email: simon@genorayamerica.com Phone: (822) 4366729

Related Public Records

Same Entity

GENORAY CO., LTD.

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
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005843418. Last updated year: 2026. Please use registration number 3005843418 when referencing this establishment in official correspondence.