Lunit, Inc.
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories2
Latest Approval2026-04-23
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260320 | Lunit INSIGHT MMG (v1.1.10) | QDQ | 2026-04-23 | View |
| 510(k) | K253796 | Lunit INSIGHT DBT (V1.2) | QDQ | 2026-03-26 | View |
| 510(k) | K242652 | Lunit INSIGHT DBT v1.1 | QDQ | 2024-10-04 | View |
| 510(k) | K231470 | Lunit INSIGHT DBT | QDQ | 2023-11-06 | View |
| 510(k) | K211678 | Lunit INSIGHT MMG | QDQ | 2021-11-17 | View |
| 510(k) | K211733 | Lunit INSIGHT CXR Triage | QFM | 2021-11-10 | View |
No matching devices.