FDA 510(k) Application Details - K183144

Device Classification Name	More FDA Info for this Device
510(K) Number	K183144
Device Name	uMC 560i
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	Shumei Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2018
Decision Date	12/19/2019
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