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510(k) Data Aggregation

    K Number
    K081076
    Device Name
    VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
    Manufacturer
    VELOCITY MEDICAL SOLUTIONS, LLC
    Date Cleared
    2008-06-20

    (65 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VELOCITY MEDICAL SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAI) is not intended for mammography diagnosis.
    Device Description
    Version 2.0 of VelocityAIS, also marketed as VelocityAI with this version, is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices. Version 2.0 of the product contains the additional features of: Automated deformable registration. Anatomical atlas based segmentation tools. Operating systems compatibility with MicroSoft Windows XP Home and Professional (Service Pack 2), MicroSoft Vista Home and Professional, Linux (CentOS) and MacOSX (Leopard). VelocityAIS (VelocityAI) is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
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    K Number
    K070248
    Device Name
    VELOCITYAIS
    Manufacturer
    VELOCITY MEDICAL SOLUTIONS, LLC
    Date Cleared
    2007-03-01

    (35 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VELOCITY MEDICAL SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VelocityAIS is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS is not intended for mammography diagnosis.
    Device Description
    VelocityAIS is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices. VelocityAIS is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
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