FDA 510(k) Application Details - K241312

Device Classification Name	More FDA Info for this Device
510(K) Number	K241312
Device Name	TeraRecon Cardiac.Chambers.MR (1.0.0)
Applicant	TeraRecon,Inc. 4309 Emperor Boulevard, Suite 310 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	Alexis Ferrier 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	05/09/2024
Decision Date	11/05/2024
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