Lunit INSIGHT DBT v1.1— 510(k) K242652

Substantially Equivalent

Lunit, Inc.

FDA 510(k) clearance K242652 for Lunit INSIGHT DBT v1.1, Substantially Equivalent on 2024-10-04. 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: 2024-09-04
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Special
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
K253796 — Lunit INSIGHT DBT (V1.2)2026-03-26
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.