Search Results
Found 3 results
510(k) Data Aggregation
K Number
K133521Device Name
AZE PHOENIX SOFTWARE
Manufacturer
Date Cleared
2014-04-11
(147 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AZE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlaceTM workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlaceTM workstation.
AZE Phoenix is not indicated for mammography use. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
AZE Phoenix is a distributed client-server radiological review station that allows easy selection, review, processing and time-series comparison of multi-modality DICOM-compliant radiological images of patients. The AZE Phoenix software accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or image archives) for viewing image manipulation, communication, printing, and quantification. AZE Phoenix queries, retrieves, and sends DICOM compliant radiological images of patients to and from any number of DICOM Picture Archiving and Communication Systems (PACS) images sources. Phoenix collects all retrieved image series from all time-points and imaging modalities associated with a patient in a single patient centric list. Phoenix capabilities include: side-by-side and fusion image display; two-dimensional length, size, and angle measurements; Response Evaluation Criteria in Solid Tumors (RECIST) guideline measurements; image alignment by registration; tagging images to rapidly query and display image; customizable hanging protocol display layouts; and the ability to push specific image series to AZE VirtualPlace™ workstation (cleared under K060453) for in depth series specific analysis.
Ask a Question
Ask a specific question about this device
K Number
K102534Device Name
AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
Manufacturer
Date Cleared
2011-05-24
(263 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AZE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AZE VirtualPlace - MR Flow Analysis software option for use with AZE VirtualPlace workstation is intended for post-processing of DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves. The MR Flow Analysis software calculates and displays the following parameters: mean/minimum/maximum and standard deviation of blood velocity in the selected region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output, and provides graphs of the velocity and volume. These parameters may be useful for a trained physician in supporting the determination of a diagnosis.
Device Description
AZE VirtualPlace - MR Flow Analysis software is an optional post-processing software designed to be installed on and used with AZE VirtualPlace workstation (cleared under K060453), which accepts, transfers, displays, stores, and digitally process DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. The MR Flow Analysis retrieves velocity-encoded MRI imaging data via electric media (offline), such as CD-ROM, or digital network (online), and facilitates the visualization and quantitative analysis for arterial vessels and heart valves. The MR Flow Analysis enables to calculate blood flow velocity and flow volume in region(s) of interest (ROI[s]) from the velocity-encoded MR data, and provide quantitative and visual analysis by displaying graphical parameters such as Mean/Minimum/Maximum velocity, Standard deviation, Velocity and volume flow as function of time, Stroke volume, and Cardiac output.
Ask a Question
Ask a specific question about this device
K Number
K060453Device Name
AZE VIRTUALPLACE
Manufacturer
Date Cleared
2006-03-09
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AZE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AZE VirtualPlace is an image processing workstation that accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. When interpreted by a trained physician, filmed or displayed images on the VirtualPlace monitor may be used as a basis for diagnosis, except in the case of mammography images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
The AZE VirtualPlace utilizes DICOM images as it facilitates reviewing, printing, storing, communications, and transferring multi-modality images from a variety of diagnostic imaging systems, such as CT, MR. The AZE VirtualPlace consists of workstation, monitor, keyboard and mouse. The AZE VirtualPlace is provided as basic software with additional software modules available for various features/functions.
Ask a Question
Ask a specific question about this device
Page 1 of 1