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510(k) Data Aggregation
K Number
K053610Device Name
ABARIS
Manufacturer
TRAXTAL TECHNOLOGIES INC.
Date Cleared
2006-04-19
(113 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
TRAXTAL TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.
Device Description
The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.
The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.
Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.
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