Lunit Inc.

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

6 AI-enabled medical devices from Lunit Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-04-23	K260320	Lunit INSIGHT MMG (v1.1.10)	Lunit, Inc.	Radiology
2026-03-26	K253796	Lunit INSIGHT DBT (V1.2)	Lunit, Inc.	Radiology
2024-10-04	K242652	Lunit INSIGHT DBT v1.1	Lunit Inc.	Radiology
2023-11-06	K231470	Lunit INSIGHT DBT	Lunit Inc.	Radiology
2021-11-17	K211678	Lunit INSIGHT MMG	Lunit Inc.	Radiology
2021-11-10	K211733	Lunit INSIGHT CXR Triage	Lunit Inc.	Radiology

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