Medical Device Manufacturer · KR , Seoul

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

6 submissions · 6 cleared · Since 2021

Recent clearances: Lunit INSIGHT MMG (v1.1.10), Lunit INSIGHT DBT (V1.2), Lunit INSIGHT DBT v1.1

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)
K260320 · QDQ
Radiology · 83d
Cleared Mar 26, 2026
Lunit INSIGHT DBT (V1.2)
K253796 · QDQ
Radiology · 118d
Cleared Oct 04, 2024
Lunit INSIGHT DBT v1.1
K242652 · QDQ
Radiology · 30d
Cleared Nov 06, 2023
Lunit INSIGHT DBT
K231470 · QDQ
Radiology · 168d
Cleared Nov 17, 2021
Lunit INSIGHT MMG
K211678 · QDQ
Radiology · 169d
Cleared Nov 10, 2021
Lunit INSIGHT CXR Triage
K211733 · QFM
Radiology · 159d
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