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FDA 510(k)

Lunit INSIGHT MMG (v1.1.10)

K-Number: K260320 · 2026-04-23

ApplicantLunit, Inc.
Decision Date2026-04-23
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lunit INSIGHT MMG (v1.1.10) is a medical device manufactured by Lunit, Inc.. It received FDA 510(k) clearance on 2026-04-23 under approval number K260320. 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 MMG (v1.1.10)?

Lunit INSIGHT MMG (v1.1.10) is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Lunit, Inc.. The 510(k) number is K260320.

When was Lunit INSIGHT MMG (v1.1.10) approved by the FDA?

Lunit INSIGHT MMG (v1.1.10) received FDA 510(k) clearance on 2026-04-23, under approval number K260320.

What company makes Lunit INSIGHT MMG (v1.1.10)?

Lunit INSIGHT MMG (v1.1.10) is manufactured by Lunit, Inc..

What is the FDA product code for Lunit INSIGHT MMG (v1.1.10)?

The FDA product code for Lunit INSIGHT MMG (v1.1.10) is QDQ.

Other Devices by Lunit, Inc.

K211678Lunit INSIGHT MMG K211733Lunit INSIGHT CXR Triage K231470Lunit INSIGHT DBT K242652Lunit INSIGHT DBT v1.1 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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