FDA.reportPublic FDA data

RAYENCE CO., LTD.

Matched from indexed company URL: Rayence Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30090483843009048384RAYENCE CO., LTD.1N2026-01-0114,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil Hwaseong-si Gyeonggi KR 18449

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1294521752749654K2438492430TCA with Xmaru WMUE2025-03-12
1294521752174859K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)MQB2024-09-09
1294521484051235K2403710909FCC, 0909FCC-HSMQB2024-03-07
1294521182260461K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFMQB2023-06-21
1294521336229710K220689Vatech ClismileNJM2022-05-06
1294521644218080K2127530909FCB, 1212FCAMQB2021-10-18
1294521391783600K2109851717FCCMQB2021-04-28
1294521137707379K2029022430MCA with Xmaru WMUE2021-06-21
1294521402696211K2027221212FCAMQB2020-10-26
1294521968919770K2017961717SCV, 1717SGVMQB2020-07-23
1294521332308946K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)LLZ2019-04-30
1294521693002891K183478ClearON MobileLLZ2019-03-01
1294521080511504K1714201717SCC_127um and 1717SCC_140umMQB2017-06-09
1294521744825515K1714191717SGC_127um and 1717SGC_140umMQB2017-06-09
1294521940770336K1714181417WCC_127um and1417WCC_140umMQB2017-06-12
1294521226797611K1714171417WGC_127um and 1417WGC_140umMQB2017-06-12
1294521944499688K1625191717WCC / 1717WGCMQB2016-10-06
1294521972847368K1625181012WCC, 1012WGCMQB2016-10-06
1294521802118863K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareLLZ2016-04-08
1294521594901071K153060Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-SMUH2015-11-10
1294521443669391K151707EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iMUH2015-07-19
1294521907050465K1501501717SGN / 1717SCN Digital Flat Panel X-ray DetectorMQB2015-03-27
1294521023250304K141566SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCCMQB2014-07-16
1294521890707818K141563SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGCMQB2014-07-16
1294521143537528K140646DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717GMQB2014-04-11
1294521824917781K140060DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000AMQB2014-05-13
1294521079825484K140056DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000AMQB2014-05-13
1294521112463788K133409DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGAMQB2014-02-21
1294521043864608K131114DIGITAL FLAT PANEL X-RAY DETECTORMQB2013-09-17
1294521303253766K130935DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCAMQB2013-07-02
1294522072034160K123345DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCAMQB2013-03-12
1294521879431284K122928DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGAMQB2013-01-30
1294521252187477K122919DIGITAL FLAT PANEL X-RAY DETECTOR11417PCAMQB2013-01-01
1294521652463844K122182DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGCMQB2012-08-16
1294521786519580K122173DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCCMQB2012-10-19
1294521630847724K121132EZSENSOR P DIGITAL INTRAORAL SENSORMQB2012-05-10
1294521759178301K113630DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGAMQB2011-12-29
1294521765354551K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSORMUH2009-12-02
1294521988557310

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB292024-09-09
LLZ32019-04-30
MUH32015-11-10
MUE22025-03-12
NJM12022-05-06

PMN#

GUDID#

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