Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Lunit Inc. with 6 510(k) clearances and 6 AI-enabled devices. The most recent is a 510(k) clearance dated Apr 23, 2026: Lunit INSIGHT MMG (v1.1.10).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 23, 2026 | Lunit INSIGHT MMG (v1.1.10)K260320 · QDQ | 510(k) clearances |
| Apr 23, 2026 | Lunit INSIGHT MMG (v1.1.10)K260320 · Radiology | AI-enabled devices |
| Mar 26, 2026 | Lunit INSIGHT DBT (V1.2)K253796 · QDQ | 510(k) clearances |
| Mar 26, 2026 | Lunit INSIGHT DBT (V1.2)K253796 · Radiology | AI-enabled devices |
| Oct 4, 2024 | Lunit INSIGHT DBT v1.1K242652 · QDQ | 510(k) clearances |
| Oct 4, 2024 | Lunit INSIGHT DBT v1.1K242652 · Radiology | AI-enabled devices |
| Nov 6, 2023 | Lunit INSIGHT DBTK231470 · QDQ | 510(k) clearances |
| Nov 6, 2023 | Lunit INSIGHT DBTK231470 · Radiology | AI-enabled devices |
| Nov 17, 2021 | Lunit INSIGHT MMGK211678 · QDQ | 510(k) clearances |
| Nov 17, 2021 | Lunit INSIGHT MMGK211678 · Radiology | AI-enabled devices |
| Nov 10, 2021 | Lunit INSIGHT CXR TriageK211733 · QFM | 510(k) clearances |
| Nov 10, 2021 | Lunit INSIGHT CXR TriageK211733 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
