FDA 510(k) Application Details - K241984

Device Classification Name	More FDA Info for this Device
510(K) Number	K241984
Device Name	Hi-D Imaging 4TAVR
Applicant	Hi-D Imaging AG Technoparkstrasse 2 Winterthur 8406 CH Other 510(k) Applications for this Company
Contact	Utku Gulan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2024
Decision Date	04/02/2025
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