FDA 510(k) Application Details - K240411

Device Classification Name	More FDA Info for this Device
510(K) Number	K240411
Device Name	uAI Portal
Applicant	Shanghai United Imaging Intelligence Co., Ltd. No. 701 Yunjin Road, Xuhui District Shanghai 200232 CN Other 510(k) Applications for this Company
Contact	Xiaojing Zhao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2024
Decision Date	09/06/2024
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