FDA 510(k) Application Details - K171198

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K171198
Device Name	System, X-Ray, Tomography, Computed
Applicant	Neusoft Medical Systems Co., Ltd. No. 16, Shiji Road Hunnan Industrial Area Shenyang 110179 CN Other 510(k) Applications for this Company
Contact	Shao Xiancheng 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	04/24/2017
Decision Date	12/07/2017
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