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Sources: EU EUDAMED, US FDA
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BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
FDA Enforcement
Class II
·Terminated·Brainlab AG·December 6, 2017
MCI Medical Care Instruments GmbH
Manufacturer
🇩🇪 Germany
Allergen Discs Mais
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
chi-enterprise, Christopher Schneider
Importer
🇩🇪 Germany·1 Manufacturer
MCI Medical Care Instruments GmbH
Importer
🇩🇪 Germany
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Authorized representative
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Authorized representative
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