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FDA 510(k)

Lunit INSIGHT CXR Triage

K-Number: K211733 · 2021-11-10

ApplicantLunit, Inc.
Decision Date2021-11-10
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lunit INSIGHT CXR Triage is a medical device manufactured by Lunit, Inc.. It received FDA 510(k) clearance on 2021-11-10 under approval number K211733. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lunit INSIGHT CXR Triage?

Lunit INSIGHT CXR Triage is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Lunit, Inc.. The 510(k) number is K211733.

When was Lunit INSIGHT CXR Triage approved by the FDA?

Lunit INSIGHT CXR Triage received FDA 510(k) clearance on 2021-11-10, under approval number K211733.

What company makes Lunit INSIGHT CXR Triage?

Lunit INSIGHT CXR Triage is manufactured by Lunit, Inc..

What is the FDA product code for Lunit INSIGHT CXR Triage?

The FDA product code for Lunit INSIGHT CXR Triage is QFM.

Other Devices by Lunit, Inc.

K211678Lunit INSIGHT MMG K231470Lunit INSIGHT DBT K242652Lunit INSIGHT DBT v1.1 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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