Data / Medical devices / South Korea / Brightonix Imaging Inc.
Brightonix Imaging Inc.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Brightonix Imaging Inc. is registered with the FDA (registration 3034246184) in Seoul, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034246184
- Address
- #B203, #409, Seongsu AK Valley 76, Yeonmujang-gil, Seongdong-gu, Seoul, South Korea, 04784
- Owner or operator
- Brightonix Imaging Inc. (10091856)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 20, 2025
- Registered through
- 2026
- Brand names listed
- PHAROS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 15, 2025 | K250170 | PHAROS | KPS | Substantially Equivalent | Brightonix Imaging | accessdata.fda.gov |
Compare with other makers
Updated August 15, 2025. 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.