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.. Device class: 2.

Clearance details

Applicant: Lunit, Inc.
Product code: Code QDQ
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2025-11-28
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Lunit, Inc.

K260320 — Lunit INSIGHT MMG (v1.1.10)2026-04-23
K242652 — Lunit INSIGHT DBT v1.12024-10-04
K231470 — Lunit INSIGHT DBT2023-11-06
K211678 — Lunit INSIGHT MMG2021-11-17
K211733 — Lunit INSIGHT CXR Triage2021-11-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.