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BioTraceIO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTracelO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available. During the ablation procedure BioTraceIO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTracelO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures. BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively. Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success. The physician should not rely on BioTraceIO Precisions about patient management post treatment nor should BioTraceIO Precision serve as a substitute for any other assessment method, e.g., CT scans.

BioTracelO Precision is a stand-alone software application with tools and features designed to assist users in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTracelO Precision is a software application that uses a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging. The streamed ultrasound images are captured and analyzed by the BioTracelO algorithm. providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTracelO Precision also provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM), after the completion of the procedure (Offline Mode).

VisAble.IO is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with liver ablation procedures. VisAble.IO is controlled by the user via a user interface. VisAble.IO imports images from CT and MR scanners and facility PACS systems for display and processing during liver ablation procedures. VisAble.IO is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

VisAble.IO is a stand-alone software application with tools and features designed to assist users in planning ablation procedures as well as tools for treatment confirmation. The use environment for VisAble.IO is the Operating Room and the hospital healthcare environment such as interventional radiology control room. VisAble.IO has five distinct workflow steps: - Data Import - . Anatomic Structures Segmentation (Liver, Hepatic Vein, Portal Vein, Ablation Target) - . Instrument Placement (Needle Planning) - Ablation Zone Segmentation - . Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis) Of these workflow steps, two (Anatomic Segmentation, and Instrument Placement) make use of the planning image. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Segmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools designed to support the evaluation of the ablation procedure's technical performance in the confirmation image volume. Key features of the VisAble.IO Software include: - . Workflow steps availability - Manual and automated tools for anatomic structures and ablation zone segmentation - Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images - . Image fusion and registration - . Compute achieved margins and missed volumes to help the user assess the coverage of the ablation target by the ablation zone - . Data saving and secondary capture generation The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the ablation target and ablation zones. The software system runs on a dedicated computer and is intended for display and processing, of a Computed Tomography (CT) and Magnetic Resonance (MR), including contrast enhanced images. The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment. VisAble.IO uses several algorithms to perform operations to present information to the user in order for them to evaluate the planned and post ablation zones. These include: - . Segmentation - . Image Registration - . Measurement and Quantification VisAble.IO is intended to be used for ablations with the following ablation instruments: For needle planning, the software currently supports the following needle models: - Medtronic: Emprint Antenna 15CM, 20CM, 30CM - - -NeuWave Medical: PR Probe 15CM, 20CM; PR XT Probe 15CM, 20CM; LK Probe 15CM, 20CM; LK XT Probe 15CM, 20CM - -H.S. Hospital Service: AMICA Probe 15 CM, 20 CM, 27 CM. For treatment confirmation (including segmentation and registration), the software is compatible with all ablation devices as these functions are independent from probes/power settings.

BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTraceIO Lite generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24 hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available. During the ablation procedure BioTraceIO Lite overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Lite is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures. BioTraceIO Lite is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Lite does not support the use of multiple needles, either simultaneously or consecutively. The physician should not rely on BioTraceIO Lite BTM alone in decisions about patient management post treatment nor should BioTraceIO Lite serve as a substitute for any other assessment method, e.g., CT scans.

BioTraceIO Lite is a software application that uses a computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging. The streamed ultrasound images are captured and analyzed by the BioTraceIO algorithm, providing a visual display of the expected ablation zone (calculated based on technical parameters provided by the ablation manufacturer datasheet), namely the Reference Ablation Zone (RAZ), during the procedure (Online Mode - Figure 1). Thirty (30) minutes after the completion of the procedure, BioTraceIO Lite provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM) (Offline Mode - Figure 2). Once in Offline Mode, it is not possible to return to Online Mode. The BTM is displayed only in Offline Mode, 30 minutes after the ablation procedure has been completed, and cannot be visualized in Online Mode, during the procedure. Information from the ultrasound system streams in only one direction, to the BioTracelO Lite software. BioTraceIO Lite utilized in either Online or Offline mode does not control or change the functions or parameters of the ultrasound system, or the ablation device used during the liver ablation procedure. The BioTraceIO Lite application is installed on a dedicated, off-the-shelf, computer workstation with pre-defined minimal requirements and is controlled by the user via an independent user interface, which is separate from both the ablation system and the ultrasound system. The workstation is connected by video output to a compatible ultrasound system to be used during the liver tumor ablation procedure.

VisAble.IO is a Computed Tomography (CT) image processing software package available for use with liver ablation procedures. VisAble.IO is controlled by the user via a user interface. VisAble.IO imports images from CT scanners and facility PACS systems for display and processing during liver ablation procedures. VisAble.IO is used to assist physicians in planning liver ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

VisAble.IO is a stand-alone software application with tools and features designed to assist users in planning ablation procedures as well as tools for treatment confirmation. The use environment for VisAble.IO is the Operating Room and the hospital healthcare environment such as interventional radiology control room. VisAble.IO has five distinct workflow steps: - Data Import - Anatomic Structures Segmentation (Liver, Hepatic Vein, Portal Vein, Ablation Target) - Instrument Placement (Needle Planning) - Ablation Zone Segmentation - Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis) Of these workflow steps, two (Anatomic Segmentation and Instrument Placement) make use of the planning image. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Seqmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools designed to support the evaluation of the ablation procedure's technical performance in the confirmation image volume. Key features of the VisAble.IO Software include: - Workflow steps availability - Manual and automated tools for anatomic structures and ablation zone segmentation - Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images - Image fusion and registration - Compute achieved margins and missed volumes to help the user assess the coverage of the ablation target by the ablation zone - Data saving and secondary capture generation The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the ablation target and ablation zones. The software system runs on a dedicated computer and is intended for display and processing, of a Computed Tomography (CT), including contrast enhanced images. The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment. VisAble.IO uses several algorithms to perform operations to the user in order for them to evaluate the planned and post ablation zones. These include: - Seamentation - Image Registration - Measurement and Quantification VisAble.IO is intended to be used for ablations with the following ablation instruments: For needle planning, the software currently supports the following needle models: - Medtronic: Emprint Antenna 15CM, 20CM, 30CM - NeuWave Medical: PR Probe 15CM, 20CM: PR XT Probe 15CM, 20CM: LK ー Probe 15CM, 20CM; LK XT Probe 15CM, 20CM For treatment confirmation (including seqmentation and registration), the software is compatible with all ablation devices as these functions are independent from probes/power settings.