FDA 510(k) Application Details - K183143

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K183143
Device Name	System, X-Ray, Tomography, Computed
Applicant	Shangai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shangai 201807 CN Other 510(k) Applications for this Company
Contact	Shumei Wang 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	11/13/2018
Decision Date	01/03/2019
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