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CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset. The results of CT Perfusion V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. The device does not alter the original image. CT Perfusion V1.0 is not intended to be used as a standalone diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. Patient management decisions should not solely be based on CT Perfusion V1.0 results. CT Perfusion V1.0 can be integrated and deployed through technical platforms, responsible for transferring, storing, converting formats, notifying of detected image variations and display DICOM of imaqing data.

The CT perfusion V1.0 application can be used to automatically compute qualitative as well as quantitative perfusion maps based on the dynamic (first-pass) effect of a contrast agent (CA). The perfusion application assumes that the input data describes a well-defined and transient signal response following rapid administration of a contrast agent. Olea Medical proposes CT Perfusion V1.0 as an image processing application, Picture Archiving Communications System (PACS) software module that is intended for use in a technical environment, which incorporates a Medical Image Communications Device (MICD) (21 CFR 892.2020) as its technical platform. CT Perfusion V1.0 image processing application is designed as a docker installed on a technical platform, a Medical Image Communications Device. The CT Perfusion V1.0 application takes as input a full CT perfusion (CTP) sequence acquired following the injection of an iodine contrast agent. By processing these input image series, the application provides the following outputs: - . Parametric maps. - Volume 1 and volume 2 segmentation in DICOM format. Fusion of segmented Volume 1 and 2 and CTP map could be provided in PNG and DICOM secondary captures. - . Mismatch computation: - Mismatch volume = Volume 2-Volume 1 - Mismatch ratio = Volume 2/Volume 1 O - Relative Mismatch = (Volume 2-Volume 1)/Volume 2*100. O The CT Perfusion V1.0 offers automatic volume seqmentations based on a set of maps and thresholds. The user is able to tune/adjust these thresholds and the maps associated to thresholds in the configuration files.

Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained radiologists and surgeons. Olea S.I.A. Neurovascular V1.0 is intended to: - display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform, - . allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs. The device does not alter the original image information and is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. Trained radiologists and surgeons are responsible for viewing the full set of native images per the standard of care.

Olea S.I.A. Neurovascular V1.0 is a visualization of docker applications results. It is an interface embedded on Olea S.I.A. V1.0 platform and uses the components of Olea S.I.A. V1.0 platform to display the outputs of docker applications to which it is entirely dedicated. Olea S.I.A. Neurovascular V1.0 allows the user to visualize native DICOM series and docker applications outputs and to modify parameters that are optional inputs of these applications. Olea S.I.A. Neurovascular V1.0 interaction with the Olea S.I.A. technical platform and docker applications To be used, Olea S.I.A. Neurovascular V1.0 needs: - o a technical base, which is provided by Olea S.I.A. V1.0 platform; and - 0 one or more applications installed on the Olea S.I.A. V1.0 platform that provide outputs that can be managed by Olea S.I.A. Neurovascular V1.0. The technical platform: - receives outputs from docker applications; ● - o makes these outputs available to related DICOM viewers. If the docker applications are compatible with Olea S.I.A. Neurovascular V1.0, they are proposed as the default software to visualize the outputs; - 0 retrieves the modified parameters in Olea S.I.A. Neurovascular V1.0 to be able to relaunch the concerned docker applications with these new input parameters. Olea S.I.A. Neurovascular V1.0 does not contain any calculation feature or any algorithm (deterministic or Al). Olea S.I.A. Neurovascular V1.0 operating principles and technological characteristics Olea S.I.A. Neurovascular V1.0 is an interface embedded on Olea S.I.A. V1.0 platform. Olea S.I.A. Neurovascular V1.0 communicates with API that exists on Olea S.I.A. V1.0 platform only. Olea S.I.A. Neurovascular V1.0 is launched via a link to a web browser and a secure connection. Olea S.I.A. Neurovascular V1.0 receives data coming from docker applications. These data can either be maps, VOIs, or metrics. Olea S.I.A. Neurovascular V1.0 is able to display these results on a dedicated user interface designed in accordance with the clinical need that provides tools to visualize and manipulate images. There is no Olea S.I.A. Neurovascular V1.0 functionality on top of the applications cleared functionalities: the subject device only serves for display of cleared outputs and/or information. Olea S.I.A. Neurovascular V1.0 also gives the possibility to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display is updated with the reprocessed outputs.

MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted imaging (DWI) (2) MR FLAIR images. The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow: - computation of the map relative to the water diffusion, i.e., ADC map; . - . extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images. The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. The device does not alter the original medical image. MR DWI/FLAIR Measurement V1.0 is not intended to be used as a standalone diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. Patient management decisions should not solely be based on MR DWI/FLAIR Measurement V1.0 results. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data.

Olea Medical proposes MR DWI/FLAIR Measurement V1.0 as an image processing application, Picture Archiving Communications System (PACS) software module that is intended for use in a technical environment which incorporates a Medical Image Communications Device as its technical platform. MR DWI/FLAIR Measurement V1.0 is an executable application which can run on the OLEA Platform. The OLEA Platform is a Medical Image Communications Device and outside the scope of this submission. MR DWI/FLAIR Measurement V1.0 is a docker totally independent from the OLEA platform in which it is integrated and has a dedicated Input/Output channels to be able to be integrated and deployed through any compatible configurable technical platform. Input DICOM images are received via the dedicated file system in which the application is integrated. When launched, the MR DWI/FLAIR Measurement V1.0 will retrieve and automatically analyze the image series. The output images will be sent to the same dedicated file system and can be visualized from any DICOM viewer by loading these results from the allocated file system. To be used, the MR DWI/FLAIR Measurement V1.0 docker needs an independent technical base, which is provided by a Medical Image Communications Device (MICD). The technical platform allows the docker to: - receive the inputs - provide the outputs - . visualize the outputs through Olea Platform viewer and/or export to other third party DICOM viewers.

MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI). The results of MR Diffusion Perfusion Mismatch V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained radiologists and surgeons are responsible for viewing the full set of native images per the standard of care. The device does not alter the original medical image. MR Diffusion Mismatch V1.0 is not intended to be used as a standalone diagnostic device and shall not be used to make decisions with diagnosis or therapeutic purposes. Patient management decisions should not solely be based on MR Diffusion Perfusion Mismatch V1.0 results. MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms, responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data.

The MR Diffusion Perfusion Mismatch V1.0 application can be used to automatically compute gualitative as well as quantitative perfusion maps based on the dynamic (first-pass) effect of a contrast agent (CA). The perfusion application assumes that the input data describes a well-defined and transient signal response following rapid administration of a contrast agent. Olea Medical proposes MR Diffusion Perfusion Mismatch V1.0 as an image processing application, Picture Archiving Communications System (PACS) software module that is intended for use in a technical environment which incorporates a Medical Image Communications Device as its technical platform.

Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. When interpreted by a skilled physician, Functional MR V1.0 provides information that may be used in a clinically useful context. Patient management decisions should not be based solely on the results of Functional MR V1.0.

The functional MRI technique consists of analyzing the blood-oxygen-level dependent (BOLD) contrast images. This is a type of specialized brain and body scan is used to map neural activity in the brain or spinal cord of humans by imaging the change in blood flow (hemodynamic response) related to energy use by brain cells. Olea Medical proposes the Functional MR V1.0 as an optional medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software module that is intended for use with the Olea Sphere® V3.0 software package (K152602). Functional MR V1.0 software application runs on a standard "off-the-shelf" PC workstation.

breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere 3.0 software package. It is intended to be used by trained breast imaging physicians and trained MRI technologists. breastscape V1.0 includes a software module (BreastApp) that supports the visualization, analysis, and reporting of lesions measurements and analysis. breastscape V1.0 supports the evaluation of dynamic MR data acquired during contrast administration and the calculation of parameters related to the uptake characteristics. breastscape V1.0 performs other user selected processing functions (such as image subtraction, multiplanar and oblique reformats, 3D renderings). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. breastscape V1.0 can also be used to provide measurements of the segmented tissue volumes (volumes of interest) based on uptake characteristics. These measurements include volume measurement, distances of volumes of interest to anatomical landmarks, 3D longest diameter and 2D long and short axis. breastscape V1.0 includes the option to add annotations based on the fifth edition of the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. breastscape V1.0 may be used as an image viewer of multi-modality digital images, including ultrasound and mammography. breastscape V1.0 is not intended for primary interpretation of digital mammography images. breastscape V1.0 includes a software module (BreastLoc) to assists users in planning MR guided breast interventional procedures. Using information from MR images, regarding userspecified target lesion and fiducial location coordinates, the software gives calculation of the targeted region of interest (such as suspected lesion) depth. When interpreted by a skilled physician, breastscape V1.0 provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be based solely on the results of breastscape V1.0.

breastscape V1.0 is an optional PACS software tool that is intended for use with the Olea Sphere V3.0 software package, cleared under K152602. The software accesses image series in DICOM format through Olea Sphere V3.0, which is a software package used to perform image viewing, processing and analysis of medical images. breastscape V1.0 is made of two software modules: BreastApp and BreastLoc. 1. BreastApp BreastApp is designed to assist in the visualization, analysis and reporting of Magnetic Resonance Imaging (MRI) breast studies. This module supports the evaluation of dynamic MR breast data acquired during contrast administration (DCE-MRI), and the calculation of parameters related to the lesion uptake characteristics. This module provides semi-automatic segmentation of volumes of interest, distance measurements and lesion volume measurements. BreastApp provides the features below: - Visualization of registered MR image series. It includes well-established to standard image viewing, MIPs, reformats and 3D volume rendering. - Visualization of Mammography and Ultrasound image series for display purpose only. - Evaluation of dynamic MR breast data acquired during contrast administration. It includes: - The computation of image subtractions (subtractions of each time point/phase image of the dynamic series with the 1st time point (baseline) image to highlight tissue with contrast enhancement). - The display of time intensity signal curves (kinetics curves) showing tissue contrast enhancement evolution over time. - The detection and display of the kinetics curve showing the worst kinetics behavior (most important washout among pixels having peak enhancement superior at 50% enhancing threshold). - The computation of semi-quantitative kinetics maps that are derived from the time intensity signal curves and showing uptake characteristics (e.g., Time to Maximum contrast Enhancement, Wash in, Washout, etc.). - Automatic detection of breast morphological structures. It includes the automatic detection of nipple position, chest and skin border. The user can further adjust them if needed. - Semi-automatic lesion segmentation. It includes: - Highlighting tissues showing significant contrast agent uptake based on an uptake threshold. - Semi-automatic segmentation of the suspected lesion identified by the user. The user can further adjust the segmentation if needed or even manually segment the suspected lesion. - Automatic computation of the suspected lesion 2D/3D diameter and lesion volume. - Automatic computation of distances between the suspected lesion and the morphological structures (distances to nipple, chest and skin). The user can further adjust the distances if needed. - Reporting of user-selected findings and assessment through a dedicated breast report. It includes the option to add annotations based on the Fifth Edition of American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. The software automatically reports the localization of the suspected lesion on a dedicated breast sector map. The position can be further adjusted by the user if needed. - Follow-up for multiple (more than two) studies from same patient. It includes tools to enhance the visualization and analysis of patient follow-up studies through the same layout. 2. BreastLoc The BreastLoc module is designed to assist users in planning MR-guided breast interventional procedures. Based on user-specified target lesion and fiducial location coordinates, BreastLoc is used to compute and display the following features: - Needle insertion block position within the grid diagram; - Needle insertion point activation in the block; - Depth of introducer, representing the graduation value where to put the depth stop on the introducer sheath; - Needle insertion path display on native images.

Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (e.g. dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the white matter structure in the brain or more generally the central nervous system. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g. over time without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as: Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module - the calculation of parameters related to leakage of injected contrass material from intravascular to extracellular space. Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion. Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate. Metabolic Module - the calculation of parameters related to the fat fraction based on a MR technique using opposedphase imaging.

Olea Sphere V3.0 is a medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software, compliant with the DICOM standard and running on Windows or Linux operating systems. Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. The main features of the software are: - Image Loading & Saving - Image Viewing - Image Manipulation - Image Analysis - Imaging Processing - Perfusion post-processing - Permeability post-processing - Arterial Spin Labeling (ASL) - Diffusion-Weighted Imaging (DWI) / Tensor Imaging post-processing (DTI) / Intra-Voxel Incoherent Motion (IVIM) - Fiber Tracking post-processing - Collage - Relaxometry post-processing - Metabolic post-processing Depending on the purpose of the imaging, the following optional plug-in are used by the software: - DWI (for MR imaging) - DTI (for MR imaging) - Perfusion (for MR and CT imaging) - Permeability (for MR and CT imaging) - Kinetics (for MR imaging) - ASL (for MR imaging) - Analysis (for MR and CT imaging) - Olea Vision (for MR imaging) - IVIM (for MR imaging) - Collage (for MR imaging) - Metabolic (for MR imaging) - Relaxometry (for MR imaging) The main users of the program are medical imaging professionals who need to visualize and analyze images acquired primarily with MRI or CT systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations

Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities. including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This functionality is referred to as: Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module - the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.

Olea Sphere is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard and running on Windows, Macintosh or Linux operating systems. Olea Sphere allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may vield clinically useful information.

Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This functionality is referred to as: Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module - the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.

Olea Sphere is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard and running on Windows, Macintosh or Linux operating systems. Olea Sphere allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. The main features of the software are: - Image Loading & Saving - Image Viewing - Image Manipulation - Image Analysis - Imaging Processing - Perfusion Post-processing - Permeability Post-processing - Diffusion Weighted Image / Tensor Image Post-processing - Fiber Tracking Post-processing The main users of the program are medical imaging professionals who need to visualize and analyze images acquired primarily with MRI or CT systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.