Chrysalis Intelligence · Sponsors · Lunit, Inc.

Lunit, Inc.

Seoul, KR · 6 510(k) clearances

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Total clearances

6

2021-11-10 → 2026-04-23

Last 12 months

2

Product codes

2

Most recent

2026-04-23

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Class II	Radiology	5	2026-04-23
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Class II	Radiology	1	2021-11-10

Filings

All 510(k) clearances (6)

Date	K-number	Device	Code	Class	Specialty
2026-04-23	K260320	Lunit INSIGHT MMG (v1.1.10)	QDQ	Class II	Radiology
2026-03-26	K253796	Lunit INSIGHT DBT (V1.2)	QDQ	Class II	Radiology
2024-10-04	K242652	Lunit INSIGHT DBT v1.1	QDQ	Class II	Radiology
2023-11-06	K231470	Lunit INSIGHT DBT	QDQ	Class II	Radiology
2021-11-17	K211678	Lunit INSIGHT MMG	QDQ	Class II	Radiology
2021-11-10	K211733	Lunit INSIGHT CXR Triage	QFM	Class II	Radiology