Data / Medical devices / South Korea / Drgem Corporation
Drgem Corporation: FDA-registered device maker in Gwangmyeong-si Gyeongbuk, South Korea, 11 510(k) clearances
Drgem Corporation is registered with the FDA (registration 3006551157) in Gwangmyeong-si Gyeongbuk, South Korea. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006551157
- Address
- 7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro, Gwangmyeong-si Gyeongbuk, South Korea, 14322
- Owner or operator
- DRGEM CORPORATION (9101499)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 11, 2007
- Registered through
- 2026
- Brand names listed
- DIAMOND 5A, DIAMOND 6A, DIAMOND 8A, DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,, DXC-RMH, DXC-RML, FDR Clinica FGXR-E20S, FDR Clinica FGXR-E25S, FDR Clinica FGXR-E32S, FDR Clinica FGXR-E40S, FDR Clinica FGXR-EC20S, FDR Clinica FGXR-EC25S, FDR Clinica FGXR-EC32S, FDR Clinica FGXR-EC40S, FDR Clinica FGXR-EC50S, FDR clinica FGXR-32S, FDR clinica FGXR-40S, FDR clinica FGXR-52S, FDR clinica FGXR-68S, FDR clinica FGXR-82S, FDR clinica FGXR-C32S, FDR clinica FGXR-C40S, FDR clinica FGXR-C52S, FDR clinica FGXR-U32S, FDR clinica FGXR-U40S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collimator, Manual, Radiographic | IZX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Complaint file establishment, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 14, 2026 | K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | IZL | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| August 22, 2025 | K251443 | PROMO | IZL | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| January 7, 2025 | K242019 | GXR-Series Diagnostic X-Ray System | KPR | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| December 16, 2024 | K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | IZL | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| September 19, 2023 | K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | KPR | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| September 24, 2020 | K202572 | GXR-Series Diagnostic X-Ray System | KPR | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| September 10, 2020 | K202156 | DIAMOND-5A/6A/8A | KPR | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| May 19, 2020 | K201124 | TOPAZ Mobile DR System | IZL | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| October 1, 2019 | K192453 | DIAMOND-5A/6A/8A | KPR | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| March 8, 2019 | K182537 | RADMAX Digital Imaging Software | LLZ | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| February 5, 2019 | K183388 | JADE Mobile X-Ray | IZL | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Mobile
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Tube Mount, X-Ray, Diagnostic
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Stationary
- All makers of Holder, Radiographic Cassette, Wall-Mounted
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.