FDA 510(k) Applications Submitted by Lunit Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K231470 05/22/2023 Lunit INSIGHT DBT Lunit Inc.
K211678 06/01/2021 Lunit INSIGHT MMG Lunit Inc.
K211733 06/04/2021 Lunit INSIGHT CXR Triage Lunit Inc.
K242652 09/04/2024 Lunit INSIGHT DBT v1.1 Lunit Inc.


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