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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 the device name listed in this FDA 510(k) record. The listed applicant is Lunit, Inc.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) 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. The listed applicant is Lunit, Inc.. The 510(k) number is K211733.

When did Lunit INSIGHT CXR Triage receive FDA 510(k) clearance?

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

Who is the listed applicant for Lunit INSIGHT CXR Triage?

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 CXR Triage?

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

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)K242652Lunit INSIGHT DBT v1.1K231470Lunit INSIGHT DBTK211678Lunit INSIGHT MMG

Related Devices (Code: QFM)

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.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-AiK243808Rayvolve PTX-PEAZmedK243548BriefCase-TriageAidoc Medical , Ltd.

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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