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FDA 510(k)

Lunit INSIGHT DBT v1.1

K-Number: K242652 · 2024-10-04

ApplicantLunit, Inc.
Decision Date2024-10-04
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lunit INSIGHT DBT v1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Lunit, Inc.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K242652. 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 v1.1?

Lunit INSIGHT DBT v1.1 is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Lunit, Inc.. The 510(k) number is K242652.

When did Lunit INSIGHT DBT v1.1 receive FDA 510(k) clearance?

Lunit INSIGHT DBT v1.1 received FDA 510(k) clearance on 2024-10-04, under 510(k) number K242652.

Who is the listed applicant for Lunit INSIGHT DBT v1.1?

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 v1.1?

The FDA product code for Lunit INSIGHT DBT v1.1 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)K253796Lunit INSIGHT DBT (V1.2)K231470Lunit 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

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

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