Lunit INSIGHT MMG

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

Lunit Inc.

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

Pre-market Notification Details

Device IDK211678
510k NumberK211678
Device Name:Lunit INSIGHT MMG
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Applicant Lunit Inc. 15 Floor, 27 Teheran-ro-2-gil, Gangnam-gu, Seoul,  KR 06241
ContactJoohee Lee
CorrespondentJohn Smith
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeQDQ  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-01
Decision Date2021-11-17

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