6 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: France
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27671
Certificate
MDD Annex VI·FIM Médical·GMED SAS·2 Basic UDI-DIs
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023
Kaio-Dia
Importer
🇫🇷 France·1 Manufacturer
FIM Médical
System producer
🇫🇷 France
Kaio-Dia
Authorized representative
🇫🇷 France·1 Manufacturer·2023 Devices