Lunit INSIGHT CXR Triage

510(k) Number

K211733 ↗

FDA Product Code

QFM

FDA applicant

Lunit, Inc.

Device Class

Class II

Regulation

21 CFR Part 892.2080

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Lunit INSIGHT CXR Triage 1.0

  Class II

  GUDID on market

• Lunit Insight MMG (v1.1.10)

  Class II

  CE/MDR FDA 510(k) K260320 Active Cleared 23 Apr 2026

• Lunit INSIGHT DBT (V1.2)

  Class II

  FDA 510(k) K253796 Active Cleared 26 Mar 2026

• Lunit INSIGHT DBT v1.1

  Class II

  CE/MDR FDA 510(k) K242652 Active Cleared 4 Oct 2024

• Lunit INSIGHT MMG

  Class IIa

  FDA 510(k) K211678 Active Cleared 17 Nov 2021 CE/MDR +1authorizations

• Lunit INSIGHT CXR

  Class IIa

  CE/MDR

See all devices from Lunit Inc. →