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Lunit, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242652Lunit INSIGHT DBT v1.1October 4, 2024
K231470Lunit INSIGHT DBTNovember 6, 2023
K211678Lunit INSIGHT MMGNovember 17, 2021
K211733Lunit INSIGHT CXR TriageNovember 10, 2021