FDA 510(k) Application Details - K193271

Device Classification Name	More FDA Info for this Device
510(K) Number	K193271
Device Name	uAI EasyTriage-Rib
Applicant	Shanghai United Imaging Intelligence Co., Ltd. No. 199, Huanke Road Shanghai 201210 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	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2019
Decision Date	01/15/2021
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