FDA 510(k) Application Details - K233749

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K233749
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 & Technological Develop 100176 CN Other 510(k) Applications for this Company
Contact	Wenqing Tian 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	11/22/2023
Decision Date	02/22/2024
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