FDA 510(k) Application Details - K242652

Device Classification Name	More FDA Info for this Device
510(K) Number	K242652
Device Name	Lunit INSIGHT DBT v1.1
Applicant	Lunit Inc. 4-8 F, 374, Gangnam-daero, Gangnam-gu Seoul 06241 KR Other 510(k) Applications for this Company
Contact	Suhyoung Bahk 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	09/04/2024
Decision Date	10/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review