FDA 510(k) Application Details - K213891

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K213891
Device Name	System, Image Processing, Radiological
Applicant	YIWEI Medical Technology Co., Ltd Room1001,MaiKelongBuilding,No.6,Gaoxin South 6thRoad, Dist.Gaoxin,Yuehai Street,Dist.Nanshan Shenzhen 518057 CN Other 510(k) Applications for this Company
Contact	Eric Ke Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2021
Decision Date	02/24/2023
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