FDA 510(k) Application Details - K242781

Device Classification Name	More FDA Info for this Device
510(K) Number	K242781
Device Name	cvi42 Software Application
Applicant	Circle Cardiovascular Imaging Inc. Suite 1800, 707 8 Avenue SW Calgary T2P 1H5 CA Other 510(k) Applications for this Company
Contact	Omar Naimi 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	09/16/2024
Decision Date	10/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review