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Medical DevicesKOSDAQ 12231061 approvals

GENORAY Co., LTD.

Official website

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

As of 2026-10-10, GENORAY Co., LTD. has 48 Korean MFDS device approvals, 13 US FDA clearances/approvals, 1 PubMed-indexed paper on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2001 and listed on KOSDAQ in 2018, Genoray specializes in X-ray imaging diagnostic devices. Its Medical segment produces the C-arm, used for real-time imaging during orthopedic and neurosurgical procedures, and Mammography for breast imaging, while its Dental segment produces the 2D Panorama imaging system, 3D CT for implant surgery, and Portable X-ray units. It operates an integrated Medical-Dental R&D lab and runs FLEXLAB as a separate software organization to expand into medical services, and as of the report date had no material non-recurring contracts.

Regulatory approvals

data.go.kr · openFDA

48 Korean MFDS device approvals · 2002–2025 / 13 US FDA 510(k) · 2015–2025

  • FDAGT300; GT300-C2025-10-08
    510(k) · TraditionalRadiologyK250060
  • FDAHESTIA2025-07-17
    510(k) · TraditionalRadiologyK243420
  • MFDSMedical image, analog to digital transform, dental2025-02-07
    Product approval · Class 2제인 25-4111 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2024-10-25
    Product approval · Class 2제인 24-966 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2024-08-01
    Product approval · Class 2제인 24-739 호
  • MFDSTable, x-ray system, diagnostic, electrically-powered2024-07-17
    Product approval · Class 1제신 24-900 호
  • MFDSX-ray system, diagnostic, computed tomography, arm2024-04-29
    Product approval · Class 2제인 24-445 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2024-03-13
    Product approval · Class 2제인 24-437 호
  • FDADVAS (DVAS-M, DVAS-W)2023-12-08
    510(k) · TraditionalDentalK232085
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2023-10-31
    Product approval · Class 2제인 23-1016 호
  • MFDSMedical image, analog to digital transform, dental2023-09-21
    Product approval · Class 2제인 23-5113 호
  • FDAGenX-CR2023-09-13
    510(k) · TraditionalDentalK232158
Show 49 more
  • FDAOscar 15 & Oscar 15i2023-07-20
    510(k) · TraditionalRadiologyK230787
  • FDAPAPAYA 3D & PAPAYA 3D Plus2022-05-19
    510(k) · TraditionalRadiologyK220392
  • FDAPAPAYA & PAPAYA Plus2022-05-19
    510(k) · TraditionalDentalK220423
  • MFDSDental x-ray system, general-purpose, intraoral, analogue2022-04-27
    Product approval · Class 2제인 22-4336 호
  • FDAZEN-2090 Turbo2022-03-09
    510(k) · TraditionalRadiologyK211780
  • MFDSMammographic x-ray system, stationary, digital2021-03-09
    Product approval · Class 2제인 21-4184 호
  • MFDSDental x-ray system, general-purpose, intraoral, analogue2021-01-19
    Product approval · Class 2제인 21-4036 호
  • FDAPAPAYA 3D Premium & PAPAYA 3D Premium Plus2020-09-16
    510(k) · TraditionalRadiologyK200469
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2020-03-25
    Product approval · Class 2제인 20-218 호
  • FDAOSCAR (OSCAR Prime, OSCAR Classic)2018-08-17
    510(k) · TraditionalRadiologyK181943
  • FDAPORT-X IV2018-03-07
    510(k) · TraditionalDentalK172810
  • FDAOSCAR 152018-02-09
    510(k) · TraditionalRadiologyK172180
  • MFDSX-ray system, diagnostic, portable, analogue2017-06-02
    Product approval · Class 2제인 17-4433 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2017-04-17
    Product approval · Class 2제인 17-270 호
  • MFDSDental x-ray system, general-purpose, intraoral, analogue2017-02-24
    Product approval · Class 2제인 17-4125 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2017-02-24
    Product approval · Class 2제인 17-146 호
  • FDAPAPAYA 3D Plus2015-12-10
    510(k) · TraditionalRadiologyK150354
  • MFDSX-ray system, diagnostic, computed tomography, arm2015-02-16
    Product approval · Class 2제인 15-217 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2015-01-29
    Product approval · Class 2제인 15-133 호
  • MFDSDental x-ray system, panoramic, digital2013-02-05
    Product approval · Class 2제인 13-336 호
  • MFDSDental image, Picture archiving and communication system, software, class 2Revoked2012-11-27
    Product approval · Class 2제인 12-1507 호
  • MFDSMammographic x-ray system, stationary, digital2011-07-26
    Product approval · Class 2제인 11-833 호
  • MFDSX-ray system, diagnostic, computed tomography, armRevoked2011-03-11
    Product approval · Class 2제인 11-251 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2010-10-01
    Product approval · Class 3제허 10-995 호
  • MFDSX-ray system, diagnostic, computed tomography, armRevoked2010-01-27
    Product approval · Class 2제허 10-68 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2010-01-22
    Product approval · Class 2제인 10-54 호
  • MFDSMammographic x-ray system, stationary, analogueRevoked2009-11-09
    Product approval · Class 2제허 09-923 호
  • MFDSX-ray system, diagnostic, computed tomography, armRevoked2009-02-06
    Product approval · Class 2제허 09-87 호
  • MFDS유방촬영용X선장치Revoked2008-05-10
    Product approval · Class 3제허 08-274 호
  • MFDSMedical image, analog to digital transform, dentalRevoked2007-12-06
    Product approval · Class 2제인 07-688 호
  • MFDSDental x-ray system, panoramic, digitalRevoked2007-06-15
    Product approval · Class 2제허 07-323 호
  • MFDSX-ray system, diagnostic, portable, analogueRevoked2007-06-02
    Product approval · Class 2제인 07-296 호
  • MFDSX-ray system, diagnostic, portable, analogueRevoked2007-04-17
    Product approval · Class 2제인 07-216 호
  • MFDS방사선용증감지Revoked2007-04-03
    Product approval · Class 1경인 수신 07-23 호
  • MFDS디지털엑스선촬영장치Revoked2006-02-17
    Product approval · Class 3제허 06-115 호
  • MFDS치과진단용엑스선발생장치Revoked2005-12-07
    Product approval · Class 3제허 05-958 호
  • MFDSMammographic x-ray system, stationary, analogueRevoked2005-09-07
    Product approval · Class 2제인 05-726 호
  • MFDS이미지인텐시화이어엑스선투시촬영장치Revoked2005-08-22
    Product approval · Class 3제허 05-671 호
  • MFDS이미지인텐시화이어엑스선투시촬영장치Revoked2005-06-02
    Product approval · Class 3제허 05-474 호
  • MFDSShield, radiation, partitionRevoked2005-02-25
    Product approval · Class 1경인 제신 05-20 호
  • MFDS엑스선방어용칸막이Revoked2005-02-25
    Product approval · Class 1경인 제신 05-21 호
  • MFDSX-ray system, diagnostic, portable, analogueRevoked2005-01-11
    Product approval · Class 2제인 05-13 호
  • MFDS이동형엑스선장치Revoked2004-12-24
    Product approval · Class 3제허 04-1288 호
  • MFDS유방촬영용엑스선장치Revoked2004-01-09
    Product approval · Class 2제허 04-45 호
  • MFDS치과진단용엑스선발생장치Revoked2003-11-28
    Product approval · Class 2제허 03-1070 호
  • MFDSMammographic x-ray system, stationary, analogue2003-08-22
    Product approval · Class 2제인 03-724 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digital2003-03-20
    Product approval · Class 2제인 03-239 호
  • MFDSFluoroscopic x-ray system, general-purpose, mobile, digitalRevoked2002-05-15
    Product approval · Class 3제허 02-405 호
  • MFDS방사선용증감지Revoked2002-01-19
    Product approval · Class 1경인 수신 02-113 호

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 62 more patents

AI reads

MAA server logs · IP-verified
62
Times AI engines pulled GENORAY Co., LTD.'s records

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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 10, 2026

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Companies approved for the same productsMedical Devices

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

ValueAddedTechnologyCo.,Ltd.9 shared

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

Ray Co., Ltd.4 shared

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

SHINHUNG CO.,LTD3 shared

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

SGHEALTHCARE CO.,LTD.3 shared

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

REMEDI Inc.2 shared

Founded in 2012 and listed on KOSDAQ in 2026, REMEDI develops portable X-ray imaging devices based on its low-dose, miniaturized X-ray technology.

DRGEM CORPORATION2 shared

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

DRTECH Corporation2 shared

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

JPI Healthcare Co., Ltd.2 shared

JPI Healthcare, founded 1980, makes X-ray imaging device components and equipment, listed on KOSDAQ in August 2025.

JW PHARMACEUTICAL2 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.

RAYENCE CO.,LTD.1 shared

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

Vieworks Co., Ltd.1 shared

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

INFINITT Healthcare Co., Ltd.1 shared

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

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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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