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Data / Medical devices / South Korea / DRGEM Corporation (Gimcheon Factory)

DRGEM Corporation (Gimcheon Factory): FDA-registered device maker in Gimcheon-si Gyeongbuk, South Korea, 13 510(k) clearances

DRGEM Corporation (Gimcheon Factory) is registered with the FDA (registration 3029916061) in Gimcheon-si Gyeongbuk, South Korea. It lists 14 device types. The FDA files 13 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch DRGEM Corporation (Gimcheon Factory)
FDA registration number
3029916061
Address
213, Saneopdanji-ro, Eomo-myeon, Gimcheon-si, Gyeongsangbuk-do, Republic of Korea, Gimcheon-si Gyeongbuk, South Korea, 39536
Owner or operator
DRGEM CORPORATION (9101499)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
May 11, 2007
Registered through
2026
Brand names listed
DIAMOND 5A, DIAMOND 6A, DIAMOND 8A, DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,, DS20, DS30, DXC-RMH, DXC-RML, DXT-10M, DXT-11L and more

Devices it lists

DeviceProduct codeClassRoleSource
Assembly, Tube Housing, X-Ray, DiagnosticITY1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Collimator, Manual, RadiographicIZX2Manufactureraccessdata.fda.gov
Generator, High-Voltage, X-Ray, DiagnosticIZO1Manufactureraccessdata.fda.gov
Holder, Radiographic Cassette, Wall-MountedIXY1Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
System, X-Ray, MobileIZL2Manufactureraccessdata.fda.gov
System, X-Ray, StationaryKPR2Manufactureraccessdata.fda.gov
Table, Radiographic, Non-Tilting, PoweredIZZ2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Tube Mount, X-Ray, DiagnosticIYB1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 14, 2026K260085RAYMO Mobile X-ray System (Model: RAYMO)IZLSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
August 22, 2025K251443PROMOIZLSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
January 7, 2025K242019GXR-Series Diagnostic X-Ray SystemKPRSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
December 16, 2024K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)IZLSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
September 19, 2023K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)KPRSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
September 15, 2022K221089P12 Elite Series Digital Color Doppler Ultrasound SystemIYNSubstantially EquivalentSonoscape Medical Corp.accessdata.fda.gov
September 24, 2020K202572GXR-Series Diagnostic X-Ray SystemKPRSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
September 10, 2020K202156DIAMOND-5A/6A/8AKPRSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
May 19, 2020K201124TOPAZ Mobile DR SystemIZLSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
October 1, 2019K192453DIAMOND-5A/6A/8AKPRSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
March 8, 2019K182537RADMAX Digital Imaging SoftwareLLZSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
February 5, 2019K183388JADE Mobile X-RayIZLSubstantially EquivalentDRGEM Corporationaccessdata.fda.gov
September 3, 2015K152396S12 Digital Color Doppler Ultrasound SystemIYNSubstantially EquivalentSonoscape Medical Corp.accessdata.fda.gov

Compare with other makers

Updated May 14, 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.