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510(k) Data Aggregation

    K Number
    K153056
    Device Name
    Hermes Medical Imaging Suite v5.6
    Manufacturer
    HERMES MEDICAL SOLUTIONS, AB
    Date Cleared
    2016-06-01

    (224 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERMES MEDICAL SOLUTIONS, AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HERMES Medical Imaging Suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquistion stations.
    Device Description
    The Hermes Medical Imaging Suite provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
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    K Number
    K142631
    Device Name
    Hermes Medical Imaging Suite v5.5
    Manufacturer
    HERMES MEDICAL SOLUTIONS, AB
    Date Cleared
    2014-12-18

    (92 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERMES MEDICAL SOLUTIONS, AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HERMES Medical Imaging suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
    Device Description
    The base product design of Hermes Medical Imaging Suite v5.5 is the same as for the Hermes Medical Imaging Suite v5.4 (K140269). A modification has been made in the reconstruction software Hybrid Recon™ where a new feature is added to enable quantitative reconstruction. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
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    K Number
    K140269
    Device Name
    HERMES MEDICAL IMAGING SUITE V5.4
    Manufacturer
    HERMES MEDICAL SOLUTIONS, AB
    Date Cleared
    2014-05-08

    (94 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERMES MEDICAL SOLUTIONS, AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
    Device Description
    The base product design of Hermes Medical Imaging Suite v5.4 is the same as for the Hermes Medical Imaging Suite v5.3 (K131233). A modification has been made of the product where the imaging processing application BRASS™ has been transferred from the Oracle® Solaris environment to the Microsoft® Windows environment. BRASS™ has also been updated with improved support for management and analysis of amyloid PET imaging as described in the 510(k) submission. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medical imaging data transferred from other workstation or acquisition stations.
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    K Number
    K131233
    Device Name
    HERMES MEDICAL IMAGING SUITE V5.3
    Manufacturer
    HERMES MEDICAL SOLUTIONS, AB
    Date Cleared
    2013-07-16

    (76 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERMES MEDICAL SOLUTIONS, AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HERMES Medical Imaging suite that provides software application used to process, display, analyze and manage nuclear medical imaging data transferred from other workstation or acquisition stations.
    Device Description
    The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
    Ask a Question
    K Number
    K121278
    Device Name
    HERMES MEDICAL IMAGING SUITE V5.2
    Manufacturer
    HERMES MEDICAL SOLUTIONS, AB
    Date Cleared
    2012-12-18

    (232 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERMES MEDICAL SOLUTIONS, AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
    Device Description
    The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
    Ask a Question

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