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 |
|