Data / Medical devices / South Korea / Oncosoft Inc.
Oncosoft Inc.: FDA-registered device maker in Seoul, South Korea, 2 510(k) clearances
Oncosoft Inc. is registered with the FDA (registration 3036758982) in Seoul, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036758982
- Address
- 37 Myeongmul-gil Seodaemun-gu, Seoul, South Korea, 03776
- Owner or operator
- Oncosoft Inc. (10092859)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- February 27, 2025
- Registered through
- 2026
- Brand names listed
- OncoStudio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 2, 2026 | K260528 | OncoStudio | QKB | Substantially Equivalent | Oncosoft. Inc., | accessdata.fda.gov |
| February 24, 2025 | K242994 | OncoStudio (OS-01) | QKB | Substantially Equivalent | Oncosoft. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 2, 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.