Lunit INSIGHT DBT (V1.2)— 510(k) K253796

Substantially Equivalent

Lunit, Inc.

FDA 510(k) clearance K253796 for Lunit INSIGHT DBT (V1.2), Substantially Equivalent on 2026-03-26. Applicant: Lunit, Inc..

Clearance details

Applicant: Lunit, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2025-11-28
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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