FDA 510(k) Application Details - K223325

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K223325
Device Name	System, Tomography, Computed, Emission
Applicant	Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai 201807 CN Other 510(k) Applications for this Company
Contact	Xin GAO Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2022
Decision Date	03/10/2023
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