FDA 510(k) Application Details - K192686

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K192686
Device Name	System, X-Ray, Tomography, Computed
Applicant	GE Hangwei Medical Systems Co.,Ltd. West Area of Building No.3, No.1 Yongchang North Road Beijing Economic and Technological Devel 100176 CN Other 510(k) Applications for this Company
Contact	Haibo He 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	09/26/2019
Decision Date	10/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review