FDA 510(k) Application Details - K240353

Device Classification Name	More FDA Info for this Device
510(K) Number	K240353
Device Name	Hyper Insight - ICH
Applicant	SK Inc. SK U-Tower, 9 Seongnam-daero, Bundang-gu Seongnam-si 13558 KR Other 510(k) Applications for this Company
Contact	Jeffrey Choi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2024
Decision Date	07/01/2024
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