Company · KR

Lunit, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (2 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	5
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	1

Decided	510(k)	Device and applicant	Code
Apr 23, 2026	K260320	Lunit INSIGHT MMG (v1.1.10) Lunit, Inc., KR	QDQ
Mar 26, 2026	K253796	Lunit INSIGHT DBT (V1.2) Lunit, Inc., KR	QDQ
Oct 4, 2024	K242652	Lunit INSIGHT DBT v1.1 Lunit, Inc., KR	QDQ
Nov 6, 2023	K231470	Lunit INSIGHT DBT Lunit, Inc., KR	QDQ
Nov 17, 2021	K211678	Lunit INSIGHT MMG Lunit, Inc., KR	QDQ
Nov 10, 2021	K211733	Lunit INSIGHT CXR Triage Lunit, Inc., KR	QFM

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.