Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010445368

FEI Number

3010445368

Entity Name

RAY CO., LTD,

City/State/Country

Yongin-si Gyeonggi, KR

Establishment Address

1F~3F, 4F(Part), 5F, 265, Daeji-ro, Yongin-si Gyeonggi 16882, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Ray Co., Ltd, (Owner Number: 10045096)

Owner / Operator Contact Address

1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si, KR-41 16882, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K950532

PMA Number

N/A

All Registered Proprietary Names

RIT-LL RIT-SL RIT-LU RIT-ML RIT-PB RIT-SU RIT-MU RIT-PA RIT-BT RAYDENT DM Rayscan A-Expert Vision 20 RAYSCAN S RAYSCAN STUDIO Vision 18 RAYPreMiere RCT800 RCT820-SC RCT820 R2 Studio Q RAYSCAN ?-SC RAYSCAN ?-OCL RAYSCAN ?-P RAYSCAN ?-OCS RAYSCAN ?+ Vision 16 RCT700 SMARTDent RAYiOS RAYiOS2 RAYDent Designer RPS500 RIOScan RAYSCAN STUDIO RAYSCAN S RAYPreMiere Vision 20 RCT800 Vision 18 RAYSCAN ?+ RCT700 Vision 16 RCT800 RAYSCAN Studio RCT600 RAYQuantum RAYDENT SG RAYSCAN ?-Expert3D RIOSensor+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2018-12-20
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2017-05-18
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2015-04-24
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2026-04-12
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2022-12-12
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2024-04-22
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-11-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-05-25
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2022-05-23
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2016-04-28
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2023-04-12
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2025-11-26
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2018-12-16
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2025-03-17
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-05-18
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2019-05-02
EAP	Unit, X-Ray, Intraoral	Dental	Class 2	872.1810	2023-11-22

Official Correspondent

No official correspondent registered.

US Agent Details

JANGTAE (BRANDON) YOO Business: RAY AMERICA INC Email: daniel.ha@rayamerica.com Phone: (201) 7450200

Related Public Records

Same Entity

Ray 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
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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3013443455	VAMCO, LLC	Albuquerque, NM, US
3030268763	OWL DENTAL	San Leandro, CA, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3014268398	LLRN PERSONAL CARE (SHENZHEN) CO.,LTD	shenzhen Guangdong, CN
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010445368. Last updated year: 2026. Please use registration number 3010445368 when referencing this establishment in official correspondence.