510(k) · Radiology

Lunit INSIGHT DBT v1.1

by Lunit Inc.

Lunit INSIGHT DBT v1.1 is an AI-enabled medical device from Lunit Inc. that the U.S. FDA cleared through 510(k) K242652 on October 4, 2024. Its lead review panel is Radiology and its primary product code is QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK242652
Pathway510(k)
Date of final decision
Company (FDA list)Lunit Inc.
Lead review panelRadiology
Primary product codeQDQ — Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Applicant (openFDA)Lunit, Inc.
Applicant locationSeoul, KR
Device classClass 2
Regulation number21 CFR 892.2090
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Lunit INSIGHT DBT v1.1 went through this pathway (K242652).

openFDA lists it as a Class 2 device under 21 CFR 892.2090. Class II devices are moderate risk and are subject to general and special controls.

Product code QDQ covers 36 devices on the FDA AI list. By decision date, this device is #21 of 36 under that code. Lunit Inc. has 6 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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