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FDA 510(k) Application Details - K211678
Device Classification Name
More FDA Info for this Device
510(K) Number
K211678
Device Name
Lunit INSIGHT MMG
Applicant
Lunit Inc.
15 Floor, 27 Teheran-ro-2-gil, Gangnam-gu,
Seoul 06241 KR
Other 510(k) Applications for this Company
Contact
Joohee Lee
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2021
Decision Date
11/17/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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