Clearance Summary
Lunit INSIGHT DBT (V1.2) received FDA 510(k) clearance under submission number K253796, sponsored by Lunit, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-03-26.
- Submission: K253796
- Applicant / Sponsor: Lunit, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2090
- Decision date: 2026-03-26
Classification & Regulation
This clearance is catalogued under FDA product code QDQ and 21 CFR 892.2090, within the Radiology review panel as a Class II device.