Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Medical equipment and related accessories, software and consumables
/
Bioimaging and radiotherapy instruments
/
Radiotherapy and radiosurgery instruments
/
Linear accelerators
/
Linear accelerators - medical device software
Linear accelerators - medical device software
Z11010192
3 devices
Devices
Radiation therapy treatment planning system
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
SunCHECK
Sun Nuclear Corporation
·
,
US
Class IIb
CE/MDR
28620200479
Active
Valid to Jan 2028
FDA 510(k)
K170307
Active
Cleared 25 Oct 2017
+1
authorizations
Radiotherapy Contouring Software
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Previous
Next