109 results
·
75ms
·
Sources: EU EUDAMED, US FDA
TomoTherapy Treatment Delivery System with iDMS
FDA 510(k)
FDA Class 2
·Radiology
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Accuray Precision Treatment Planning System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Accuray Incorporated·1 device
Cyberknife Treatment Delivery System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Accuray Incorporated·1 device
Radixact Treatment Delivery System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Accuray Incorporated·1 device
523004
Certificate
MDD Annex II (excluding section 4)·Accuray Incorporated·BSI Group The Netherlands B.V.·3 Basic UDI-DIs
Yourrad AB
Importer
🇸🇪 Sweden·3 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices