FDA 510(k) Application Details - K203256

Device Classification Name	More FDA Info for this Device
510(K) Number	K203256
Device Name	Imbio RV/LV Software
Applicant	Imbio, LLC 1015 Glenwood Avenue, Floor 4 Minneapolis, MN 55405 US Other 510(k) Applications for this Company
Contact	William McLain 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	11/04/2020
Decision Date	03/09/2021
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