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Medical DevicesKOSDAQ 22867057 approvals

Ray Co., Ltd.

Official website

KOSDAQ-listed dental medical device company offering the RAYSCAN digital diagnostic system and RAYDENT digital treatment solutions.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2004 and listed on KOSDAQ in 2019, Ray is a dental medical device company specializing in digital diagnostic systems and treatment solutions. It offers the RAYSCAN Pano panoramic imaging device, the Ceph cephalometric imaging device, the RAYSCAN CT dental CBCT device, the RIOSensor intraoral sensor, the RIOScan imaging plate scanner, the RAYDENT Solution/RAYSCAN Studio digital total solutions, the RAYDENT Studio 3D printer solution, and the RAYFACE 3D face scanner. It launched RAYFACE with AI-based automatic 3D image registration software in July 2022, and is developing a Dental Avatar generation system under a government project with the Ministry of SMEs and Startups, planned for commercialization in 2027.

Products & technology

  • RAYSCAN PanoPanoramic imaging device (2D)
  • CephCephalometric imaging device (2D)
  • RAYSCAN CTDental Cone Beam CT (CBCT) device
  • RIOSensorIntraoral X-ray sensor (IOS)
  • RIOScanImaging plate scanner (IPS)
  • RAYDENT Solution / RAYSCAN StudioDigital dentistry total solution package including CT, 3D printer, and CAD/CAM software
  • RAYDENT Studio3D printer, post-curing unit, and CAD/CAM software solution
  • RAYFACE3D face scanner

Regulatory approvals

data.go.kr · openFDA

38 Korean MFDS device approvals · 2008–2025 / 19 US FDA 510(k) · 2015–2026

  • FDARCT8002026-04-09
    510(k) · SpecialRadiologyK260462
  • FDARCT7002025-11-25
    510(k) · TraditionalRadiologyK251798
  • FDASMARTDent2025-05-21
    510(k) · TraditionalRadiologyK251109
  • FDARCT6002025-03-12
    510(k) · TraditionalRadiologyK243903
  • MFDSX-ray system, diagnostic, computed tomography, arm2025-02-20
    Product approval · Class 2제인 25-4149 호
  • FDARAYDENT SW2024-05-16
    510(k) · TraditionalDentalK233625
  • FDARAYSCAN a-Expert2024-04-18
    510(k) · TraditionalDentalK232325
  • MFDSDental image, treatment planning software2023-10-16
    Product approval · Class 2제인 23-5171 호
  • FDARAYSCAN a-Expert3D2023-08-31
    510(k) · SpecialRadiologyK232287
  • FDARCT8002023-04-11
    510(k) · SpecialRadiologyK230753
  • FDARCT7002021-11-29
    510(k) · TraditionalRadiologyK213226
  • MFDSRespirator, medicalRevoked2021-11-01
    Product approval · Class 2제인 21-4927 호
Show 45 more
  • MFDSX-ray system, diagnostic, computed tomography, arm2021-08-31
    Product approval · Class 2제허 21-733 호
  • MFDSappliance, orthodontic, resinRevoked2021-06-07
    Product approval · Class 2제인 21-4483 호
  • FDAEar-Friendly Mask2021-05-17
    510(k) · TraditionalGeneral, Plastic SurgeryK211105
  • MFDSresin, impression tray2020-11-10
    Product approval · Class 1제신 20-1649 호
  • MFDSDental x-ray system, panoramic, digital2020-03-03
    Product approval · Class 2제인 20-4173 호
  • FDARCT8002019-10-22
    510(k) · TraditionalRadiologyK192737
  • MFDSImplant, surgical, guide for medical use2019-07-10
    Product approval · Class 2제인 19-448 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2019-06-05
    Product approval · Class 2제인 19-4456 호
  • MFDSresin, crown & bridge, temporary2019-05-10
    Product approval · Class 2제인 19-4375 호
  • FDARAYSCAN a-Expert3D2019-04-24
    510(k) · SpecialRadiologyK190812
  • FDARCT8002018-12-14
    510(k) · SpecialRadiologyK182805
  • MFDSDental impression material tray2018-12-07
    Product approval · Class 1제신 18-1621 호
  • FDARCT7002018-10-16
    510(k) · SpecialRadiologyK182614
  • MFDS치과용영상전송장치소프트웨어Revoked2018-10-08
    Product approval · Class 2제인 18-4816 호
  • FDARCT8002018-07-27
    510(k) · TraditionalRadiologyK181452
  • MFDSX-ray system, diagnostic, computed tomography, arm2018-05-04
    Product approval · Class 2제인 18-4345 호
  • MFDS기타보철재료2017-12-29
    Product approval · Class 2제허 17-994 호
  • MFDSresin, crown & bridge, temporary2017-11-13
    Product approval · Class 2제인 17-4871 호
  • MFDSGuide for medical use2017-07-25
    Product approval · Class 1제신 17-868 호
  • MFDSX-ray film, dental, screen2017-02-08
    Product approval · Class 1제신 17-135 호
  • MFDS치과용영상전송장치소프트웨어2017-01-18
    Product approval · Class 2제인 17-4042 호
  • FDARCT7002016-06-20
    510(k) · TraditionalRadiologyK160525
  • MFDSMedical image, analog to digital transform, dental2016-06-16
    Product approval · Class 2제인 16-4502 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2016-05-11
    Product approval · Class 2제인 16-4389 호
  • FDARIOScan (RPS500)2016-04-15
    510(k) · TraditionalDentalK160788
  • MFDSX-ray system, diagnostic, computed tomography, arm2016-04-05
    Product approval · Class 2제인 16-4301 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2016-03-24
    Product approval · Class 2제인 16-4267 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2016-01-27
    Product approval · Class 2제인 16-4078 호
  • MFDSMedical image, analog to digital transform, dental2015-10-21
    Product approval · Class 2제인 15-4211 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2015-04-27
    Product approval · Class 2제인 15-644 호
  • FDARAYSCAN A-EXPERT 3D2015-04-17
    510(k) · TraditionalRadiologyK142247
  • FDARIS5002015-01-23
    510(k) · TraditionalRadiologyK143000
  • MFDSX-ray system, diagnostic, computed tomography, arm2014-11-24
    Product approval · Class 2제인 14-2414 호
  • MFDSDental x-ray system, panoramic, digital2014-11-24
    Product approval · Class 2제인 14-2415 호
  • MFDSDental x-ray system, panoramic, digital2014-09-22
    Product approval · Class 2제인 14-1688 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2014-09-19
    Product approval · Class 2제인 14-1679 호
  • MFDSMedical image, analog to digital transform, dental2014-09-02
    Product approval · Class 2제인 14-1588 호
  • MFDSMedical image, analog to digital transform, dental2014-04-18
    Product approval · Class 2제허 14-899 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2014-01-15
    Product approval · Class 2제인 14-132 호
  • MFDSDental x-ray system, panoramic, digital2014-01-15
    Product approval · Class 2제인 14-133 호
  • MFDSDental image, Picture archiving and communication system, software, class 22013-08-20
    Product approval · Class 2제인 13-1455 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2012-02-02
    Product approval · Class 2제인 12-146 호
  • MFDSDental x-ray system, panoramic, digital2012-02-02
    Product approval · Class 2제인 12-147 호
  • MFDSSystem, image processing device, dentalRevoked2009-07-10
    Product approval · Class 1경인 제신 09-206 호
  • MFDSDental x-ray system, panoramic/tomographic, digitalRevoked2008-03-24
    Product approval · Class 2제인 08-170 호

R&D and key agreements

Source: DART corporate disclosure

Dental Avatar 생성 통합시스템 및 응용 심미 디지털 치과 솔루션 · 개발중(2027년 상용 예정) · In-house and government-funded (Ministry of SMEs and Startups) project developing a 3D virtual patient system and CAD software for clear aligners, splints, and laminate veneer design

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.

DENTIS CO.,LTD8 shared

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

DIO Corporation6 shared

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

SHINHUNG CO.,LTD6 shared

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

ValueAddedTechnologyCo.,Ltd.6 shared

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

GENORAY Co., LTD.4 shared

Genoray, founded in 2001 and KOSDAQ-listed in 2018, manufactures medical and dental X-ray imaging diagnostic devices.

REMEDI Inc.2 shared
YUHAN CORPORATION2 shared

Founded in 1926 and listed on the KOSPI in 1962, Yuhan Corporation is a comprehensive pharmaceutical company known for its innovative drug Leclaza.

Alpha AI Co.,Ltd.1 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

anymedi Inc.1 shared

Uses AI analysis of medical imaging to 3D-print patient-specific surgical guides, implants, and simulators.

MEDYSSEY CO.,LTD1 shared

Manufactures spinal implants and metal 3D-printed patient-specific implants, exporting to over 25 countries.

Organ Eco Tech Co.,Ltd.1 shared

Organ Eco Tech, founded in 2006 and KONEX-listed in 2016, manufactures spinal implants.

SEWOONMEDICAL CO,. LTD.1 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

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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