Data / Medical devices / South Korea / DK Medical Systems Co., Ltd.
DK Medical Systems Co., Ltd.: FDA-registered device maker in Pyeongtaek-si Gyeonggi, South Korea, 4 510(k) clearances
DK Medical Systems Co., Ltd. is registered with the FDA (registration 3014403439) in Pyeongtaek-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014403439
- Address
- 52, Chupalsandan 1-gil, Paengseong-eup, Pyeongtaek-si Gyeonggi, South Korea, 17998
- Owner or operator
- DK Medical Systems Co., Ltd. (10082850)
- Roles
- Manufacturer
- First device listed
- October 7, 2021
- Registered through
- 2027
- Brand names listed
- AeroDR RS, AeroDR TX c02, DS-90A, Elin-T4A, INNOVISION-DXII, INNOVISION-EXII, INNOVISION-P5, SF-90A and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | Manufacturer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 10, 2026 | K253446 | AeroDR TX c02 | KPR | Substantially Equivalent | Dk Medical Systems Co., Ltd. | accessdata.fda.gov |
| August 1, 2025 | K250790 | INNOVISION-DXII | KPR | Substantially Equivalent | Dk Medical Systems Co., Ltd. | accessdata.fda.gov |
| July 18, 2025 | K250750 | INNOVISION-P5 | IZL | Substantially Equivalent | Dk Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 3, 2025 | K242119 | INNOVISION-EXII | KPR | Substantially Equivalent | Dk Medical System | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of Table, Radiographic, Non-Tilting, Powered
- All makers of Holder, Radiographic Cassette, Wall-Mounted
- All makers of Tube Mount, X-Ray, Diagnostic
- All makers of System, X-Ray, Mobile
Updated April 10, 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.