FDA 510(k) Application Details - K243479

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K243479
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Sonavex, Inc. 2835 O'Donnell Street Suite 200 Baltimore, MD 21224 US Other 510(k) Applications for this Company
Contact	Ralph Del Negro 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	11/08/2024
Decision Date	04/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review