FDA 510(k) Application Details - K243376

Device Classification Name	More FDA Info for this Device
510(K) Number	K243376
Device Name	uAngio AVIVA CX
Applicant	Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District Shanghai 201807 CN Other 510(k) Applications for this Company
Contact	Xin Gao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2024
Decision Date	04/28/2025
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