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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 the device name listed in this FDA 510(k) record. The listed applicant is Lunit, Inc.. It received FDA 510(k) clearance on 2026-03-26 under 510(k) 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. The listed applicant is Lunit, Inc.. The 510(k) number is K253796.

When did Lunit INSIGHT DBT (V1.2) receive FDA 510(k) clearance?

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

Who is the listed applicant for Lunit INSIGHT DBT (V1.2)?

The FDA 510(k) record lists Lunit, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Lunit, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260320Lunit INSIGHT MMG (v1.1.10)K242652Lunit INSIGHT DBT v1.1K231470Lunit INSIGHT DBTK211678Lunit INSIGHT MMGK211733Lunit INSIGHT CXR Triage

Related Devices (Code: QDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260898Transpara (2.1.0)Screenpoint Medical B.V.K260086CadAI-B DxBeamWorks, Inc.K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.K260714MammoScreen® (5)TherapixelK253825Saige-DxDeepHealth, Inc.K253682DeepHealth ProstateAIQuantib B.V.

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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