Lunit, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Lunit, Inc. has 6 FDA 510(k) cleared medical devices. Based in Seoul, KR.
Latest FDA clearance: Apr 2026. Active since 2021. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Lunit, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hogan Lovells US LLP and Hogan Lovells.
6 devices
Cleared
Apr 23, 2026
Lunit INSIGHT MMG (v1.1.10)
Radiology
83d
Cleared
Mar 26, 2026
Lunit INSIGHT DBT (V1.2)
Radiology
118d
Cleared
Oct 04, 2024
Lunit INSIGHT DBT v1.1
Radiology
30d
Cleared
Nov 06, 2023
Lunit INSIGHT DBT
Radiology
168d
Cleared
Nov 17, 2021
Lunit INSIGHT MMG
Radiology
169d
Cleared
Nov 10, 2021
Lunit INSIGHT CXR Triage
Radiology
159d