Company profile

Lunit, Inc.

Lunit, Inc. has 6 AI-enabled medical devices on the FDA list. The first decision was on November 10, 2021 and the most recent on April 23, 2026 (Lunit INSIGHT MMG (v1.1.10)). Its most common review panel is Radiology (6 devices).

6AI devices

2021First decision

2026Latest decision

1Specialties

Per year

2021202320242026

Lunit, Inc. AI devices per year: 2021 2, 2023 1, 2024 1, 2026 2

By specialty

Radiology6

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Timeline

April 23, 2026 · 510(k) K260320Lunit INSIGHT MMG (v1.1.10) · Radiology · QDQ
March 26, 2026 · 510(k) K253796Lunit INSIGHT DBT (V1.2) · Radiology · QDQ
October 4, 2024 · 510(k) K242652Lunit INSIGHT DBT v1.1 · Radiology · QDQ
November 6, 2023 · 510(k) K231470Lunit INSIGHT DBT · Radiology · QDQ
November 17, 2021 · 510(k) K211678Lunit INSIGHT MMG · Radiology · QDQ
November 10, 2021 · 510(k) K211733Lunit INSIGHT CXR Triage · Radiology · QFM