FDA 510(k) Application Details - K203448

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K203448
Device Name	System, X-Ray, Tomography, Computed
Applicant	Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengei 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	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2020
Decision Date	08/11/2021
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