FDA 510(k) Application Details - K250221

Device Classification Name	More FDA Info for this Device
510(K) Number	K250221
Device Name	StrokeSENS ASPECTS 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	Kyle Mayr Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2025
Decision Date	07/01/2025
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