FDA 510(k) Application Details - K213998

Device Classification Name	More FDA Info for this Device
510(K) Number	K213998
Device Name	cvi42 Auto Imaging Software Application
Applicant	Circle Cardiovascular Imaging Inc Suite 1100 - 800 5th Ave SW Calgary T2P 3T6 CA Other 510(k) Applications for this Company
Contact	Sydney Toutant 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	12/21/2021
Decision Date	07/28/2022
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