3 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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ADHESIVE EXL-759
FDA 510(k)
FDA Class 2
·Dental
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 20, 2016