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Medical DevicesKOSDAQ 22885092 approvals

RAYENCE CO.,LTD.

Official website

KOSDAQ-listed X-ray imaging solution company with a full lineup of medical, dental, veterinary, and industrial X-ray detectors.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2011 and listed on KOSDAQ in 2016, Rayence is a medical device company specializing in digital X-ray detectors. It develops TFT detectors for still imaging, CMOS detectors for high-resolution video imaging, and bendable I/O sensors in-house, and has expanded into the veterinary medical device market through affiliates Woorien and Woorien Pharm and overseas subsidiaries OSKO (Mexico), Myvet Imaging (U.S.), and Qpix Solutions (U.S.). Through its TFT research institute, it has developed detector products including the 1717SGC/SCC (4.2kg, under 2-second image output), the 1417PGA/PCA (3.1kg), the 1012WCA (2.7kg, imaging area more than 2 inches larger than competing products), and the 1417WGC/WCC (3.5kg).

Products & technology

  • TFT detectorX-ray detector for still imaging and large-area sensing
  • CMOS detectorHigh-efficiency, high-resolution X-ray video sensor
  • Bendable I/O SensorBendable intraoral X-ray sensor
  • 1717SGC/SCCCassette-type X-ray detector for human and small-animal use
  • 1417PGA/PCAPortable X-ray detector for human use
  • 1012WCAWired/wireless X-ray detector for veterinary and human use
  • 1417WGC/WCCCassette-mountable wired/wireless X-ray detector

Regulatory approvals

data.go.kr · openFDA

67 Korean MFDS device approvals · 2004–2026 / 25 US FDA 510(k) · 2015–2026

  • MFDSMedical image, analog to digital transform, DR, CR2026-08-19
    Product approval · Class 2제인 26-4758 호
  • FDA0909FCE, 0909FCE-HS2026-07-31
    510(k) · TraditionalRadiologyK253800
  • MFDSMedical image, analog to digital transform, DR, CR2025-10-29
    Product approval · Class 2제인 25-5002 호
  • FDA2430TCA with Xmaru W2025-03-12
    510(k) · SpecialRadiologyK243849
  • MFDSMedical image, analog to digital transform, DR, CR2025-01-17
    Product approval · Class 2제인 25-4069 호
  • MFDSMedical image, analog to digital transform, DR, CR2024-09-27
    Product approval · Class 2제인 24-897 호
  • FDADigital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)2024-09-09
    510(k) · TraditionalRadiologyK242394
  • MFDSMedical image, analog to digital transform, DR, CR2024-07-22
    Product approval · Class 2제인 24-703 호
  • MFDSMedical image, analog to digital transform, DR, CR2024-03-13
    Product approval · Class 2제인 24-281 호
  • FDA0909FCC, 0909FCC-HS2024-03-07
    510(k) · SpecialRadiologyK240371
  • MFDSMedical image, analog to digital transform, dental2023-09-26
    Product approval · Class 2제인 23-5124 호
  • FDA1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF2023-06-21
    510(k) · SpecialRadiologyK231467
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  • MFDSMedical image, analog to digital transform, DR, CR2023-06-05
    Product approval · Class 2제인 23-4790 호
  • FDAVatech Clismile2022-05-06
    510(k) · TraditionalDentalK220689
  • MFDSimplant, endosseous, fixtureRevoked2022-03-14
    Product approval · Class 3제허 22-166 호
  • FDA0909FCB, 1212FCA2021-10-18
    510(k) · SpecialRadiologyK212753
  • MFDSbracket, orthodonticRevoked2021-08-18
    Product approval · Class 2제인 21-4712 호
  • MFDSbracket, orthodonticRevoked2021-08-18
    Product approval · Class 2제인 21-4711 호
  • MFDSbracket, orthodonticRevoked2021-08-04
    Product approval · Class 2제인 21-4663 호
  • FDA2430MCA with Xmaru W2021-06-21
    510(k) · TraditionalRadiologyK202902
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2021-06-17
    Product approval · Class 2제인 21-4528 호
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2021-06-15
    Product approval · Class 2제인 21-4521 호
  • FDA1717FCC2021-04-28
    510(k) · SpecialRadiologyK210985
  • MFDSMedical image, analog to digital transform, dentalRevoked2020-11-26
    Product approval · Class 2제인 20-5036 호
  • FDA1212FCA2020-10-26
    510(k) · SpecialRadiologyK202722
  • MFDSMedical image, analog to digital transform, DR, CR2020-08-28
    Product approval · Class 2제인 20-4794 호
  • MFDSMedical image, analog to digital transform, DR, CR2020-08-28
    Product approval · Class 2제인 20-4793 호
  • FDA1717SCV, 1717SGV2020-07-23
    510(k) · SpecialRadiologyK201796
  • MFDSMedical image, analog to digital transform, DR, CR2020-07-20
    Product approval · Class 2제인 20-4639 호
  • MFDSMedical image, analysis softwareRevoked2020-04-10
    Product approval · Class 2제인 20-4273 호
  • MFDSMedical image, computer aided detection/ diagnosis software, class 22020-04-10
    Product approval · Class 2제인 20-4274 호
  • MFDSMedical image, analog to digital transform, DR, CR2019-05-23
    Product approval · Class 2제인 19-4416 호
  • FDAXmaruView V1 (Xmaru Chiroview, Xmaru Podview)2019-04-30
    510(k) · SpecialRadiologyK190866
  • FDAClearON Mobile2019-03-01
    510(k) · SpecialRadiologyK183478
  • MFDS휴대형의료영상전송장치소프트웨어Revoked2019-01-24
    Product approval · Class 2제인 19-4059 호
  • FDA1417WCC_127um and1417WCC_140um2017-06-12
    510(k) · SpecialRadiologyK171418
  • FDA1417WGC_127um and 1417WGC_140um2017-06-12
    510(k) · SpecialRadiologyK171417
  • FDA1717SGC_127um and 1717SGC_140um2017-06-09
    510(k) · SpecialRadiologyK171419
  • FDA1717SCC_127um and 1717SCC_140um2017-06-09
    510(k) · SpecialRadiologyK171420
  • MFDSMedical image, analog to digital transform, DR, CR2016-11-29
    Product approval · Class 2제인 16-4892 호
  • MFDSMedical image, analog to digital transform, DR, CR2016-11-23
    Product approval · Class 2제인 16-4875 호
  • FDA1717WCC / 1717WGC2016-10-06
    510(k) · SpecialRadiologyK162519
  • FDA1012WCC, 1012WGC2016-10-06
    510(k) · SpecialRadiologyK162518
  • FDAXmaru View V1 and Xmaru PACS, Medical Image Processing Software2016-04-08
    510(k) · SpecialRadiologyK160579
  • FDADigital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S2015-11-10
    510(k) · SpecialDentalK153060
  • MFDSMedical image, picture archiving and communication system, software, class 22015-08-18
    Product approval · Class 2제인 15-4032 호
  • FDAEzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i2015-07-19
    510(k) · SpecialDentalK151707
  • FDADigital Dental Intra Oral Sensor, EzSensor Smart2015-05-01
    510(k) · SpecialDentalK150797
  • MFDSMedical image, analog to digital transform, dental2015-04-30
    Product approval · Class 2제인 15-658 호
  • FDA1717SGN / 1717SCN Digital Flat Panel X-ray Detector2015-03-27
    510(k) · TraditionalRadiologyK150150
  • FDADigital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio2015-03-10
    510(k) · SpecialDentalK143753
  • MFDSMedical image, analog to digital transform, DR, CR2014-12-16
    Product approval · Class 2제인 14-3070 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-12-16
    Product approval · Class 2제인 14-3071 호
  • MFDSMedical image, analog to digital transform, dental2014-10-10
    Product approval · Class 2제인 14-1799 호
  • MFDSMedical image, picture archiving and communication system, software, class 22014-08-26
    Product approval · Class 2제인 14-1544 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-07-03
    Product approval · Class 2제인 14-1270 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-07-01
    Product approval · Class 2제인 14-1242 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-07-01
    Product approval · Class 2제인 14-1243 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-07-01
    Product approval · Class 2제인 14-1244 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-04-18
    Product approval · Class 2제허 14-894 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-04-18
    Product approval · Class 2제허 14-895 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-04-18
    Product approval · Class 2제허 14-896 호
  • MFDSMedical image, analog to digital transform, DR, CR2014-03-24
    Product approval · Class 2제인 14-699 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-12-26
    Product approval · Class 2제인 13-2228 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-12-26
    Product approval · Class 2제인 13-2230 호
  • MFDSMedical image, analog to digital transform, dental2013-06-13
    Product approval · Class 2제인 13-1035 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-06-07
    Product approval · Class 2제인 13-995 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-06-07
    Product approval · Class 2제인 13-996 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-05-14
    Product approval · Class 2제인 13-844 호
  • MFDSMedical image, analog to digital transform, dental2013-05-14
    Product approval · Class 2제인 13-845 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-02-27
    Product approval · Class 2제인 13-459 호
  • MFDSMedical image, analog to digital transform, DR, CR2013-02-27
    Product approval · Class 2제인 13-460 호
  • MFDSTelemetry system transmitter, dental imageRevoked2012-05-04
    Product approval · Class 2제허 12-555 호
  • MFDSMedical image, analog to digital transform, dental2012-02-29
    Product approval · Class 2제인 12-268 호
  • MFDSTelemetry system transmitter, dental imageRevoked2012-02-22
    Product approval · Class 2제허 12-217 호
  • MFDSTelemetry system transmitter, dental imageRevoked2011-12-05
    Product approval · Class 2제허 11-1319 호
  • MFDSTelemetry system transmitter, dental imageRevoked2011-10-13
    Product approval · Class 2제허 11-1136 호
  • MFDSMedical image, analog to digital transform, DR, CR2011-04-13
    Product approval · Class 2제허 11-415 호
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2011-04-13
    Product approval · Class 2제허 11-416 호
  • MFDSMedical image, analog to digital transform, DR, CRRevoked2011-02-16
    Product approval · Class 2제허 11-149 호

Showing the 80 most recent of 92 records.

R&D and key agreements

Source: DART corporate disclosure

a-Si TFT Detector, CMOS Detector, I/O Sensor 연구개발 · 상품화 완료(다수) · Conducted by the company's TFT research institute; most R&D projects result in commercialized products

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

SHINHUNG CO.,LTD8 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

DRTECH Corporation5 shared

KOSDAQ-listed digital diagnostic imaging company providing X-ray systems, detectors, and components.

Vieworks Co., Ltd.5 shared

Vieworks, founded in 1999 and KOSDAQ-listed in 2009, develops X-ray detectors and industrial camera imaging solutions.

ValueAddedTechnologyCo.,Ltd.4 shared

Founded in 1992 and KOSDAQ-listed in 2006, VATECH manufactures dental digital X-ray and CT imaging diagnostic devices.

DEEPNOID Inc.3 shared

Founded in 2008 and listed on KOSDAQ in 2021, DEEPNOID develops medical and industrial AI imaging solutions like DEEP:NEURO.

INFINITT Healthcare Co., Ltd.3 shared

Founded in 2002, INFINITT Healthcare provides PACS-centered medical imaging software and AI diagnostic aids across multiple clinical specialties.

JW PHARMACEUTICAL3 shared

Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.

SGHEALTHCARE CO.,LTD.3 shared

Founded in 2009 and KOSDAQ-listed in 2024, SGHealthcare manufactures X-ray, CT, and MRI medical imaging diagnostic devices.

DENTIS CO.,LTD2 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

DIO Corporation2 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

DRGEM CORPORATION2 shared

KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.

REMEDI Inc.2 shared

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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