FDA 510(k) Application Details - K243853

Device Classification Name	More FDA Info for this Device
510(K) Number	K243853
Device Name	Clarius Prostate AI
Applicant	Clarius Mobile Health Corp. 205-2980 Virtual Way Vancouver V5M 4X3 CA Other 510(k) Applications for this Company
Contact	Agatha Szeliga 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	12/16/2024
Decision Date	04/16/2025
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