Lunit INSIGHT CXR Triage

Radiological Computer-assisted Prioritization Software For Lesions

Lunit Inc.

The following data is part of a premarket notification filed by Lunit Inc. with the FDA for Lunit Insight Cxr Triage.

Pre-market Notification Details

Device IDK211733
510k NumberK211733
Device Name:Lunit INSIGHT CXR Triage
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant Lunit Inc. 15th Floor, 27 Teheran-ro 2-gil Seoul,  KR 06241
ContactSeulhee Jung
CorrespondentColin S. Jacob
Hogan Lovells Columbia Square 555 Thirteenth Street, Northwest Washington,  DC  20004
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-04
Decision Date2021-11-10

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