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510(k) Data Aggregation
K Number
K181247Device Name
Vitrea CT Brain Perfusion
Manufacturer
Vital Images, Inc.
Date Cleared
2018-11-20
(194 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitrea CT Brain Perfusion is a non-invasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time density curves. Vitrea CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).
Device Description
Vitrea CT Brain Perfusion is a noninvasive post-processing software that calculates cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data. It displays time density curves, perfusion characteristics in perfusion and summary maps, as well as regions of interest and mirrored regions.
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K Number
K182230Device Name
Multi Modality Viewer
Manufacturer
Vital Images, Inc.
Date Cleared
2018-09-07
(21 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Device Description
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
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K Number
K172855Device Name
Vitrea Advanced Visualization, Version 7.6
Manufacturer
Vital Images, Inc.
Date Cleared
2017-10-05
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography.
Device Description
The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- Retrieve image data over the network via DICOM
- Display of images in dedicated protocols which are automatically adapted based on exam type
- Select images for closer examination from a gallery of 2D or 3D views
- Interactively manipulate an image in real-time to visualize anatomy and pathology
- Annotate, measure, and record selected views
- Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server
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K Number
K163232Device Name
Vitrea View
Manufacturer
Vital Images, Inc
Date Cleared
2017-07-21
(246 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitrea View software is a medical image viewing and information distribution that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to. radiologists, non-radiology specialists, physicians and technologists.
When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Device Description
The Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.
The Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the web-based zero-footbrint nature of the Vitrea View software. The Virea View software offers scalability to add new users as demand grows, and may be deployed in a virtualized environment. Some of the general features include:
. Fast time-to-first-image
- Contextual launch integration with single-sign-on
- . Easy study navigation and search capability
- Supports multi-modality vendor-neutral DICOM images
- . Supports non-DICOM images
- lmages display at full diagnostic quality (with appropriate hardware)
- . Basic 2D review tools (zoom, pan, measure)
- Basic 3D and MPR viewing
- Radiology key images
- . Comparative side-by-side review, regardless of image types
- . Collaboration tools
- . Leverages traditional DICOM as well as next-generation DICOMweb image transfer protocols
- Enables federated access to across multiple data sources across multiple sites
- . Web-based zero-footprint architecture
- Secure Access on various Windows® and Mac computers through standard internet
- browsers
- . Secure Access on various iOS®, Android™, and Windows® tablet devices through the device's Internet browser
- . Secure Access on various iOS and Android smartphones through the device's Internet browser
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K Number
K163574Device Name
Multi Modality Viewer
Manufacturer
Vital Images, Inc.
Date Cleared
2017-01-26
(38 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Device Description
Multi Modality Viewer is a medical image viewer software application, available on the Vitrea software platform cleared by K150258. The application allows qualified clinicians, including physicians, radiologists and technologists, to display, navigate, manipulate and quantify medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT modalities.
The Multi-Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
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K Number
K161157Device Name
Vitrea CT Dual Energy Image View
Manufacturer
VITAL IMAGES, INC.
Date Cleared
2016-11-03
(192 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
VITAL IMAGES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be determined using the energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical and pathological structures.
Device Description
The Vitrea® CT Dual Energy Image View is a post-processing software application which functions on the Vitrea® Platform, cleared by K150258.This application allows you to load and combine two CT images, acquired from a Toshiba CT scanner with a Dual Energy protocol, of the same anatomical location; one obtained with low kV tube voltage and one obtained with high kV tube voltage. Vitrea® computes a Blended and an Enhanced image with adjustable virtual energy levels, a Virtual Non-Contrast (VNC) image, an lodine Map overlaid on one of the original or derived images, a CT graph, and a best Contrast-to-Noise Ratio (CNR) image. For the Raw Data Analysis workflow, Vitreally calculates a Monochromatic image.
The software supports Toshiba dual-energy studies containing image-based and projection-based reconstruction techniques.
- lmage-based reconstructed data consists of a standard image reconstruction of the two ● scans. Use the Dual Energy Image Domain (Two Volumes) workflow for these datasets.
- Projection-based reconstructed data consists of special material image reconstruction where . the two scans are combined to create two sets of images where a predefined material is defined, typically lodine/Water and/or Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets.
- NOTE: It is important that a description of the material is contained in the DICOM Image Comments tag (0020, 4000) for each dataset at the time of the scan. For lodine/Water projection-based reconstruction, the lodine material image should be labeled "I/H20," and the corresponding Water material image should be labeled "H20/1." For the Calcium/Water projection-based reconstruction, the Calcium material image should be labeled "Ca/H20," and the corresponding Water material image should be labeled "H20/Ca."
NOTE: The dual-energy datasets must be coincident with the same frame of reference UID.
NOTE: Available with Toshiba datasets only.
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K Number
K161419Device Name
Multi Modality Viewer
Manufacturer
VITAL IMAGES, INC.
Date Cleared
2016-07-13
(51 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VITAL IMAGES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Device Description
Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data.
lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care.
Key features:
General Viewing:
- · Linked 2D, MPR and 4D viewers for single and multi-study comparison
- · Creation of retrievable evidence and snapshots
- · User defined flexible display protocols
Access to Advanced Applications and Workflows:
- In application access to MR Stitching application
- · Evidence creation and sharing across workflows
General Image Display, Manipulation, and Analysis Tools:
- · Maximum and Minimum Intensity Projection (MIP/MinIP)
- · Identification and Display of Regions of Interest (ROIs)
- · CINE image display
- · Multi-frame display
- · Color image display
- . Simultaneous multiple studies review
- · Cross-reference lines support
- Display of selected images, series, or entire study .
- · Comparison of multiple series or studies
- · Scroll
- Pan
- Zoom
- · Focus
- · Flip (Vertically, horizontally)
- Invert
- · Rotate (Clockwise, counter-clockwise)
- · Arrow
- · Adjust Registration
- · Auto window level/width setting
- · Text/Arrow annotation (Label)
- · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI
Specialized Tools:
- · Image subtraction of two series/datasets
- · Access to semi-automated image stitching
- Study and series linking .
- · Register two different series or groups that do not share a frame of reference to link them spatially
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K Number
K160150Device Name
Vitrea CT Colon Analysis
Manufacturer
Vital Images, Inc.
Date Cleared
2016-03-16
(55 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.
Device Description
Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features:
- . Auto-seqmentation of the colon
- . Segmentation editing
- . Axial imaging, multi-planar reformatting and 3D views
- . Manual and automatic endoluminal fly-through of the colon
- . Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode
- MPR eye placement to adjust view direction down lumen
- . Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through
- . Dual Volume Viewer window format for side-by-side comparison of prone and supine studies
- Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close
- SPACE BAR to step through images containing arrows
- Prone/supine registration .
- . Polyp Probe tool to select and characterize polyps
- Polyp assessment using the C-RADS guidelines
- . Fly-through image batches and digital movies
- Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template
- . Fly-through keyboard shortcuts
- . Automatic fluid/stool tagging and subtraction
Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care.
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K Number
K151283Device Name
Lung Analysis Software
Manufacturer
Vital Images, Inc.
Date Cleared
2015-10-30
(169 days)
Product Code
JAK, LLZ
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Vital Images, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Device Description
Lung Analysis aids in measuring and characterizing lung nodules. The interface and automated tools help to efficiently determine growth patterns and compose comparative reviews. Lung Analysis is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The Lung Analysis Software requires the user to identify a nodule and to determine whether it is a GGO or solid nodule in order to use the appropriate characterization tool.
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K Number
K151919Device Name
Vitrea CT Lung Density Analysis Software
Manufacturer
VITAL IMAGES, INC.
Date Cleared
2015-10-10
(89 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
VITAL IMAGES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT thoracic datasets. Three-dimensional (3D) segmentation of the left lung and right lung, volumetric analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and follow-up evaluation of lung tissue images.
Device Description
Vitrea CT Lung Density Analysis assists in analyzing lung densities and volumes. It semiautomatically segments lung tissues with quantifiable controls and renderings to aid communication with the pulmonologist.
The key features are:
- Semi-automatic right lung, left lung, and airway segmentation .
- Visualization of lung density with color-defined Hounsfield Unit (HU) ranges ●
- . Lung density result quantification with HU density range, volume measurements, lunq density index, and the PD15% measurement
- . Density graph/histogram of the classified lung voxels' relative frequencies
- Comparison of upper and lower lung density index ratios .
- Adjustable density thresholds for refining and optimizing HU ranges ●
- Overlay of density quantification results and density graph histogram for reporting
- Export of density values and curves to CSV tables or copy to clipboard for insertion into a ● report
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