FDA 510(k) Application Details - K232331

Device Classification Name	More FDA Info for this Device
510(K) Number	K232331
Device Name	InVision Precision LVEF (LVEF)
Applicant	InVision Medical Technology Corporation 9702 Cisco St. 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	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2023
Decision Date	04/25/2024
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