FDA 510(k) Application Details - K231470

Device Classification Name	More FDA Info for this Device
510(K) Number	K231470
Device Name	Lunit INSIGHT DBT
Applicant	Lunit Inc. 4-8 F, 374 Gangnam-daero, Gangnam-gu Seoul 06241 KR Other 510(k) Applications for this Company
Contact	Hyung Tak Han 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	05/22/2023
Decision Date	11/06/2023
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