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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 a medical device manufactured by Lunit, Inc.. It received FDA 510(k) clearance on 2024-10-04 under approval 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. It is manufactured by Lunit, Inc.. The 510(k) number is K242652.

When was Lunit INSIGHT DBT v1.1 approved by the FDA?

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

What company makes Lunit INSIGHT DBT v1.1?

Lunit INSIGHT DBT v1.1 is manufactured by Lunit, Inc..

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 Devices by Lunit, Inc.

K211678Lunit INSIGHT MMG K211733Lunit INSIGHT CXR Triage K231470Lunit INSIGHT DBT K260320Lunit INSIGHT MMG (v1.1.10) K253796Lunit INSIGHT DBT (V1.2)

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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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