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MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.

myAblation Guide is a software medical device that is used in the context of percutaneous ablative procedures with straight instruments. It is used by clinical professionals in a hospital premise; it can be either deployed on compatible CT scanners or a computer workstation. The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority. myAblation Guide allows operating functions in an arbitrary sequence. In addition, it includes a structured sequence of steps for ease of utility. The application supports anatomical datasets from CT, MR, CBCT, as well as PET/CT. The application includes means and functionalities to support in: · Multimodality viewing and contouring of anatomical, and multi-parametric images such as CT, CBCT, PET/CT, MRI · Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT) · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique - Manual and semi-automatic registration using rigid and deformable registration - · Expansion of created contour structures to visualize a safety margin · Functionality to support the user in creating virtual ablation needle paths and associated virtual ablation zones derived from manufacturer data - · Export of virtual needle paths in the Dicom SSO format - · Supports the user in comparing, contouring, and ablation needle planning based on datasets acquired with different imaging modalities - Supports multimodality image fusion - · Supports user's procedure flow via a task stepper Thermal ablation cannot be triggered from myAblation Guide.

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.

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a 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 organ and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes. Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure. The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra.

Artemis is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, probe, commercially available biopsy needle guide, needle gun combination, and cryoablation systems. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement, reporting and 3-D image registration. Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate. The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, which can be examined for abnormalities by a physician. Patient information, notes, and images may be stored for future retrieval, and locations for biopsies may be selected by the physician. The system also allows previously acquired 3-D models to be recalled, aligned, or registered to the current 3-D model of the prostate, which is especially useful for patients under active surveillance. The physician may attach a commercially available biopsy needle guide compatible to the ultrasound probe and use the probe and needle to perform tissue biopsy and or cryoablation. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of Artemis during the procedure. As the ultrasound probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe with respect to the organ is tracked. Artemis is able to add, display and edit loaded plans for the procedure as well as provide the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate. In addition to standard transrectal needle guidance procedures, Artemis also supports transperineal needle guidance by mounting a Needle Guide Attachment (NGA). A commercially available needle guide compatible with the NGA is used. This NGA will be used for both biopsy and cryo needles. The NGA provides additional data to track the needle direction angle. When using transperineal mode, the procedure planning, segmentation, registration and navigation are performed in the same way as the standard transrectal procedure. The only difference lies in how the needle guide needs to be moved to target the different planned locations. For the transrectal procedure, the needle guide is always attached to the probe. Therefore moving the probe moves the needle guide. In transperineal needle guidance procedures the needle is not attached to the probe. Therefore the NGA needs to be moved to move the needle guide. Artemis highlights the closed target to the current needle guide position. Artemis offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous Ultrasound probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure. The device also provides automated reports with information and pictures from the procedure.

Ablation-fit is a medical imaging application available for use with liver ablation procedures. Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement. Ablation-fit is used to assist physicians in confirming ablation zones during follow-up. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

Ablation-fit is a stand-alone medical imaging software that integrates Reconstruction, Segmentation, Registration and Visualization algorithms into a user interface to support physicians during liver ablation treatments planning and follow-up. Ablation-fit allows to perform the entire workflow from DICOM (Digital Imaging and COmmunications in Medicine) images to 3D reconstruction of volume of interests, ablation probe placement and treatment outcome verification. Specifically, Ablation-fit main functionalities include: - Image loading from different supports (including PACS), - DICOM images handling and visualization in axial, sagittal, coronal views, - image segmentation, - tools for manual edit of segmentations. - 3D visualization, - virtualization of ablation probe placement, - pre- and post-treatment images registration. The software permits segmentation and 3D reconstruction of volumes of interest. The software contours all of this anatomic information not only in axial, sagittal, and coronal planes for 2D visualization, but also three-dimensionally. Every computed segmentation can be manually modified in the 2D axial visualization and consequently the three-dimensional mapping of the scan changes accordingly. Ablation-fit let the user simulate the virtual needle insertion and shows the desired ellipsoid of ablation. Once the ablation procedure has been performed, pre- and post-treatment scans are registered. Consequently, the software can verify whether the ablation zones entirely surrounds the lesion and the safety margin.

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.

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. · Evaluation of cardiac left ventricular function, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PE7/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). · Calculating absorbed radiation dose as a result of administering a radionuclide. · Assist with the planning and evaluation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success. When using device clinically, within the United States, the user should only use FDA approved radionly, If using with unapproved ones, this device should only be used for research purposes. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

MIM - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality: - . Manual and automatic tools for normal structure, target region, and ablation zone segmentation - lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning - Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones. - . The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed - Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.