FDA 510(k) Application Details - K242808

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K242808
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi ochigi-ken JP Other 510(k) Applications for this Company
Contact	Biggins Paul Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2024
Decision Date	05/13/2025
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