K260320
- 510(k) number
- K260320
- Device name
- Lunit INSIGHT MMG (v1.1.10)
- Applicant
- Lunit, Inc. KR
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-04-23
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260320.pdf
Official FDA record: K260320
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.