FDA 510(k) Application Details - K251728

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K251728
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Sonic Incytes Medical Corp 1788 West 5th Ave #309 Vancouver V6J1P2 CA Other 510(k) Applications for this Company
Contact	Tinuade Orimalade Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2025
Decision Date	06/26/2025
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