Data / Medical devices / South Korea / Lunit Inc.
Lunit Inc.: FDA-registered device maker in Seoul, South Korea, 6 510(k) clearances
Lunit Inc. is registered with the FDA (registration 3021230777) in Seoul, South Korea. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 23, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021230777
- Address
- 4-8F, 374, Gangnam-daero, Gangnam-gu, Seoul, South Korea, 06241
- Owner or operator
- Lunit Inc. (10076093)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 20, 2021
- Registered through
- 2027
- Brand names listed
- CXR Assist with Lunit INSIGHT CXR Triage, Lunit INSIGHT CXR Triage, Lunit INSIGHT DBT, Lunit INSIGHT DBT (V1.2), Lunit INSIGHT DBT v1.1, Lunit INSIGHT MMG, Lunit INSIGHT MMG (v1.1.10)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 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 |
|---|---|---|---|---|---|---|
| April 23, 2026 | K260320 | Lunit INSIGHT MMG (v1.1.10) | QDQ | Substantially Equivalent | Lunit, Inc. | accessdata.fda.gov |
| March 26, 2026 | K253796 | Lunit INSIGHT DBT (V1.2) | QDQ | Substantially Equivalent | Lunit, Inc. | accessdata.fda.gov |
| October 4, 2024 | K242652 | Lunit INSIGHT DBT v1.1 | QDQ | Substantially Equivalent | Lunit, Inc. | accessdata.fda.gov |
| November 6, 2023 | K231470 | Lunit INSIGHT DBT | QDQ | Substantially Equivalent | Lunit, Inc. | accessdata.fda.gov |
| November 17, 2021 | K211678 | Lunit INSIGHT MMG | QDQ | Substantially Equivalent | Lunit, Inc. | accessdata.fda.gov |
| November 10, 2021 | K211733 | Lunit INSIGHT CXR Triage | QFM | Substantially Equivalent | Lunit, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
Updated April 23, 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.