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FDA 510(k)

Lunit INSIGHT DBT (V1.2)

K-Number: K253796 · 2026-03-26

ApplicantLunit, Inc.
Decision Date2026-03-26
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lunit INSIGHT DBT (V1.2) is a medical device manufactured by Lunit, Inc.. It received FDA 510(k) clearance on 2026-03-26 under approval number K253796. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lunit INSIGHT DBT (V1.2)?

Lunit INSIGHT DBT (V1.2) is a medical device that received FDA 510(k) clearance on 2026-03-26. It is manufactured by Lunit, Inc.. The 510(k) number is K253796.

When was Lunit INSIGHT DBT (V1.2) approved by the FDA?

Lunit INSIGHT DBT (V1.2) received FDA 510(k) clearance on 2026-03-26, under approval number K253796.

What company makes Lunit INSIGHT DBT (V1.2)?

Lunit INSIGHT DBT (V1.2) is manufactured by Lunit, Inc..

What is the FDA product code for Lunit INSIGHT DBT (V1.2)?

The FDA product code for Lunit INSIGHT DBT (V1.2) is QDQ.

Other Devices by Lunit, Inc.

K211678Lunit INSIGHT MMG K211733Lunit INSIGHT CXR Triage K231470Lunit INSIGHT DBT K242652Lunit INSIGHT DBT v1.1 K260320Lunit INSIGHT MMG (v1.1.10)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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