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BioTraceIO Precision
BioTraceIO Precision is intended to provide physicians with adjunctive information in their clinical assessment ofablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.BioTraceIO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with imagefindings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. Theinformation is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of otherportions of the ablation zone is available. BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes.
Details
Device typeRadiology picture archiving and communication system workstation: A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.
FDA categoryPost-Ablation Tissue Response Prediction Software
Device ID07290019572121
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information