8 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
JTC Diagnosemittel GmbH
Manufacturer
🇩🇪 Germany
BRAINLAB CT/X-RAY LOCALIZER
FDA 510(k)
FDA Class 2
·Radiology
JTC Diagnosemittel GmbH
Importer
🇩🇪 Germany
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.
FDA Enforcement
Class II
·Terminated·Brainlab AG·February 19, 2014
JTC Diagnosemittel GmbH
Authorized representative
🇩🇪 Germany
JaviTech e.K.
Authorized representative
🇩🇪 Germany·111 Manufacturers·1816 Devices
Luxus Lebenswelt GmbH
Authorized representative
🇩🇪 Germany·191 Manufacturers·2068 Devices
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices