K253796
- 510(k) number
- K253796
- Device name
- Lunit INSIGHT DBT (V1.2)
- Applicant
- Lunit, Inc. KR
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-03-26
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253796.pdf
Official FDA record: K253796
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.