Medical Device Manufacturer · KR , Seoul

Lunit, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2021

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lunit, Inc. Radiology ✕

6 devices

1-6 of 6

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

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026