FDA 510(k) Application Details - K232459

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K232459
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Sonic Incytes #309-1788 West 5th Ave Vancouver V6J 1P2 CA Other 510(k) Applications for this Company
Contact	Barry Allen 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	08/15/2023
Decision Date	09/12/2023
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