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FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: - Performing measurements on DICOM images - Regional segmentation - Importing and presenting data from modalities (DICOM and non-DICOM), - Solving clinical calculations - Creating and distributing structured reports FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning. MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA-cleared, DICOM compatible displays for mammography.

The Synapse PACS is an enterprise-wide medical information and image management software that runs on standard "off-the-shelf" PC hardware and Software (OS, browser). Synapse is intended for communication, storage, display, manipulation, measurement, printing, and processing of images and information acquired from various medical imaging and information systems. As a Software as a Medical Device (SaMD), Synapse PACS performs these purposes without being part of a hardware medical device. FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: - Performing measurements on DICOM images - Regional segmentation - Importing and presenting data from modalities (DICOM and non-DICOM), - Solving clinical calculations - Creating and distributing structured reports

PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules. PIUR tUS inside System may be used on any adult patient aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply. The PIUR tUS inside System acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging. The PIUR tUS inside System is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).

PIUR tUS inside is a medical device which enhances standard ultrasound devices with a three-dimensional (3D) tomographic imaging method for a 3D analysis of ultrasound volumes. With PIUR tUS inside, examining physicians can make diagnostic decisions based on standard 2D as well as 3D image data integrated in an ultrasound device environment. This 3D data provides information which previously could have only been generated using other 3D imaging technologies like CT or MRI. The PIUR tUS inside runs on a compatible GE Healthcare ultrasound system. The PIUR tUS inside takes as an input a sequence of 2D ultrasound images that are transmitted through a software interface from the ultrasound to the PIUR tUS inside. In addition, the PIUR Sensor must be clipped onto the ultrasound transducer using individually designed PIUR Brackets. For image acquisition, the user moves the 2D ultrasound transducer perpendicular to the structure to be imaged over the region of interest of the patient's body. An inertial measurement unit (IMU), which is built into the PIUR Sensor, tracks the orientation of the transducer during the scan and sends this information to the ultrasound via Bluetooth. The PIUR tUS inside combines image information and sensor information to generate tomographic 3D ultrasound volumes on which image analysis can be performed. An important property of this method is the unlimited length of the acquired volume. PIUR tUS inside therefore allows recording and analyzing a complete thyroid lobe. The PIUR tUS inside and the PIUR tUS Infinity Predicate Device share most hardware and software components and algorithms. On the hardware side, both systems use the same PIUR Sensor to track probe movement during a freehand ultrasound acquisition. The data from the PIUR Sensor is transferred wirelessly through a Bluetooth connection to the software where it is being used to generate ultrasound volumes from the freehand sweep. Both systems also share the same volume compounding software algorithms, semi-automatic lobe and nodule segmentation algorithms, and volume calculation algorithms. The performance for image compounding and volume calculations are therefore the same for both systems. The main difference between the PIUR tUS inside System and the Predicate Device is the interface for image retrieval. While the Predicate Device uses the Infinity Box to transfer digital ultrasound images from a third-party ultrasound system to the software through a Wi-Fi connection, the PIUR tUS inside has direct access to the image stream through a software interface. It runs directly on the compatible ultrasound scanners: GE Healthcare LOGIQ E10 (K231966) and GE Healthcare LOGIQ E10s/Fortis (K231989). This, however, is not performance relevant as the image data remains the same. It only reduces the number of compatible ultrasound systems as a close collaboration with the ultrasound manufacturer is required. The PIUR tUS inside System acts as part of the diagnostic chain only and must not be used as a sole source for diagnostic or treatment decisions. The solution is intended to be used on patients aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply, in a non-sterile environment. The solution is not intended to be used on patients with open wounds or irritated skin or during surgery.

EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. The intended medical indication is for patients requiring review or analysis of their echocardiographic images acquired for their cardiac anatomy, structure and function. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments. The intended patient population is both healthy individuals and patients in whom an underlying cardiac disease is known or suspected; the intended patient age range is for adults (>= 22 years old) and adolescent in the age range 18 – 21 years old.

EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report.

Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. It is not intended for diagnostic purposes. Brainlab Elements Image Fusion is indicated for planning of cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It is not intended for diagnostic purposes. Brainlab Elements Image Fusion Angio is indicated for planning of cranial surgical treatments and preplanning of cranial radiotherapy treatments. Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Weighted Imaging (DWI) data for use in treatment planning procedures. It is not intended for diagnostic purposes. Brainlab Elements Fibertracking is indicated for planning of cranial surgical treatments and preplanning of cranial radiotherapy treatments. Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. It is not intended for diagnostic purposes. Brainlab Elements Contouring is indicated for planning of cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. Brainlab Elements BOLD MRI Mapping provides tools to analyze blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal. It is not intended for diagnostic purposes. Brainlab Elements BOLD MRI Mapping is indicated for planning of cranial surgical treatments.

The Brainlab Elements are applications and background services for processing of medical images including functionalities such as data transfer, image co-registration, image segmentation, contouring and other image processing. They consist of the following software applications: 1. Image Fusion 5.0 2. Image Fusion Angio 1.0 3. Contouring 5.0 4. BOLD MRI Mapping 1.0 5. Fibertracking 3.0 This device is a successor of the Predicate Device Brainlab Elements 6.0 (K223106). Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It allows co-registration of 2D digital subtraction angiography images to 3D vascular images in order to combine flow and location information. In particular, 2D DSA (digital subtraction angiography) sequences can be fused to MRA, CTA and 3D DSA sequences. Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The output is saved as 3D DICOM segmentation object and can be used for further processing and treatment planning. BOLD MRI Mapping provides methods to analyze task-based (block-design) functional magnet resonance images (fMRI). It provides a user interface with tools and views in order to visualize activation maps and generate 3D objects that can be used for further treatment planning. Brainlab Elements Fibertracking is an application for the processing and visualization of information based upon Diffusion Weighted Imaging (DWI) data, i.e. to calculate and visualize cranial white matter tracts in selected regions of interest, which can be used for treatment planning procedures.

The Viz Subdural+ (Subdural Plus) device is intended for automatic labeling, visualization and quantification of collections in the subdural space from a set of Non-Contrast Head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of collections in the subdural space identified on NCCT images. Viz Subdural + provides volumes from NCCT images acquired at a single time point. The Viz Subdural+ software is intended for labeling subdural collections and reporting the grayscale value of the collection, widest width of the subdural collection, and midline shift. The device output should be reviewed along with the patient's original images by a physician qualified to interpret brain CT images.

Viz Subdural+ is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to process and analyze non-contrast CT (NCCT) scans of the head to automatically measure the collections in the subdural region in the brain and midline shift. The device output provides visual overlays of automatically measured subdural collections where the overlay opacity (intensity) corresponds to the grayscale value of the collection within the native NCCT, and reports the total volume and widest width of the subdural collections. The device also automates and reports the measure of midline shift. The results of the automated measurement are provided in a summary series and segmentation series in DICOM format. The summary series consists of a summary table of subdural collections, snapshot of each collection and a midline shift measurement. The first slice of the Subdural+ summary series summarizes the measurement results of each subdural collection (volume and widest width), total volume and midline shift in tabular format. The summary series also contains a snapshot of each subdural collection and a snapshot of the midline shift measurement. The segmentation series shows an RGB overlay where a subdural collection is identified by a colored overlay with the color intensity corresponding to the HU values of the original image on each slice of the input series of the segmented region. On slices with an overlay representing a measured subdural collection, the volume of the subdural collection is provided. The midline shift is overlaid and provided on the slice where the midline shift is measured. Images are automatically forwarded from the Healthcare Facility and sent to Viz.ai's Backend Server after acquisition at the CT scanner. Viz Subdural+ is hosted on Viz.ai's Backend Server and automatically analyzes applicable NCCT scans that are acquired on CT scanners and are forwarded to Viz.ai's Backend Server. The results of the analysis are exported in DICOM format and are sent to a DICOM destination (e.g., PACS) where they are available for review by radiologists, neurologists, neuro-surgeons, interventional neuroradiologists, or other appropriately trained professionals to assist in the measurement of subdural collection volume, widest subdural collection width and midline shift.