FDA 510(k) Application Details - K243866

Device Classification Name	More FDA Info for this Device
510(K) Number	K243866
Device Name	InVision Precision Cardiac Amyloid
Applicant	InVision Medical Technology Corporation 9702 Cisco Street Los Angeles, CA 90034 US Other 510(k) Applications for this Company
Contact	David Ouyang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2024
Decision Date	05/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review