Data / Medical devices / South Korea / Rayence Co., Ltd.

Rayence Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 38 510(k) clearances

Name: Rayence Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Rayence Co., Ltd. is registered with the FDA (registration 3009048384) in Hwaseong-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 38 510(k) clearances under its listings, the newest dated July 31, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Rayence Co., Ltd.

FDA registration number: 3009048384
Address: 14,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil, Hwaseong-si Gyeonggi, South Korea, 18449
Owner or operator: Rayence Co., Ltd. (10036755)
Roles: Manufacturer
First device listed: March 14, 2012
Registered through: 2026
Brand names listed: 0909FCB, 1212FCA, 0909FCC, 0909FCC-HS, 0909FCE, 0909FCE-HS, 1212FCA, 1417WCC_127um, 1417WCC_140um and more

Devices it lists

Device	Product code	Class	Role	Source
Full Field Digital, System, X-Ray, Mammographic	MUE	2	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 31, 2026	K253800	0909FCE, 0909FCE-HS	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
March 12, 2025	K243849	2430TCA with Xmaru W	MUE	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
September 9, 2024	K242394	Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
March 7, 2024	K240371	0909FCC, 0909FCC-HS	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
June 21, 2023	K231467	1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
October 18, 2021	K212753	0909FCB, 1212FCA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
June 21, 2021	K202902	2430MCA with Xmaru W	MUE	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
April 28, 2021	K210985	1717FCC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
October 26, 2020	K202722	1212FCA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
July 23, 2020	K201796	1717SCV, 1717SGV	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
April 30, 2019	K190866	XmaruView V1 (Xmaru Chiroview, Xmaru Podview)	LLZ	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
March 1, 2019	K183478	ClearON Mobile	LLZ	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
June 12, 2017	K171418	1417WCC_127um and1417WCC_140um	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
June 12, 2017	K171417	1417WGC_127um and 1417WGC_140um	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
June 9, 2017	K171420	1717SCC_127um and 1717SCC_140um	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
June 9, 2017	K171419	1717SGC_127um and 1717SGC_140um	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
October 6, 2016	K162519	1717WCC / 1717WGC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
October 6, 2016	K162518	1012WCC, 1012WGC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
April 8, 2016	K160579	Xmaru View V1 and Xmaru PACS, Medical Image Processing Software	LLZ	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
November 10, 2015	K153060	Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S	MUH	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
July 19, 2015	K151707	EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i	MUH	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
March 27, 2015	K150150	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
July 16, 2014	K141566	SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
July 16, 2014	K141563	SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
May 13, 2014	K140060	DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
May 13, 2014	K140056	DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
April 11, 2014	K140646	DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
February 21, 2014	K133409	DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
September 17, 2013	K131114	DIGITAL FLAT PANEL X-RAY DETECTOR	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
July 2, 2013	K130935	DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
March 12, 2013	K123345	DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
January 30, 2013	K122928	DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
January 1, 2013	K122919	DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
October 19, 2012	K122173	DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
August 16, 2012	K122182	DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
May 10, 2012	K121132	EZSENSOR P DIGITAL INTRAORAL SENSOR	MQB	Substantially Equivalent	Humanray Co,Ltd	accessdata.fda.gov
December 29, 2011	K113630	DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
December 2, 2009	K090526	MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR	MUH	Substantially Equivalent	E-Woo Technology	accessdata.fda.gov

Compare with other makers

Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.