Lunit, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260320Lunit INSIGHT MMG (v1.1.10)April 23, 2026
K253796Lunit INSIGHT DBT (V1.2)March 26, 2026
K242652Lunit INSIGHT DBT v1.1October 4, 2024
K231470Lunit INSIGHT DBTNovember 6, 2023
K211678Lunit INSIGHT MMGNovember 17, 2021
K211733Lunit INSIGHT CXR TriageNovember 10, 2021