FDA 510(k) Application Details - K242292

Device Classification Name	More FDA Info for this Device
510(K) Number	K242292
Device Name	uAI Easy Triage ICH
Applicant	Shanghai United Imaging Intelligence Co., Ltd. No. 701 Yunjin Road, Xuhui District Shanghai 200232 CN Other 510(k) Applications for this Company
Contact	Zhao Xiaojing Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2024
Decision Date	09/24/2024
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