Transparency Registry · applicant
Lunit, Inc.: 6 FDA AI clearances
Every 510(k) clearance held by Lunit, Inc. under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| Lunit INSIGHT MMG (v1.1.10) | 2026-04-23 | QDQ |
| Lunit INSIGHT DBT (V1.2) | 2026-03-26 | QDQ |
| Lunit INSIGHT DBT v1.1 | 2024-10-04 | QDQ |
| Lunit INSIGHT DBT | 2023-11-06 | QDQ |
| Lunit INSIGHT MMG | 2021-11-17 | QDQ |
| Lunit INSIGHT CXR Triage | 2021-11-10 | QFM |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Lunit, Inc.? The disclosure rows on your entries update free on submission of public links — start here.
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