FDA 510(k) Application Details - K241849

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K241849
Device Name	Injector, Contrast Medium, Automatic
Applicant	Imaxeon Pty Ltd Unit 2 38-46 South Street Rydalmere 2116 AU Other 510(k) Applications for this Company
Contact	Anhua Hu Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	IZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2024
Decision Date	11/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review