3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·June 13, 2018
ROSA One 3.1 Brain Application
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020