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510(k) Data Aggregation

    K Number
    K162008
    Device Name
    JiveX
    Manufacturer
    VISUS TECHNOLOGY TRANSFER GMBH
    Date Cleared
    2016-09-16

    (58 days)

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

    VISUS TECHNOLOGY TRANSFER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. Note: Web-based image distribution and mobile device display are not intended for diagnostic purposes.
    Device Description
    JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. A Communication Server is communicating, storing, and archiving DICOM data and also renders images for the web based image distribution. Fat clients, rich in rendering and image manipulation functionality, are medical diagnostic and viewing workplaces. When using FDA cleared monitors diagnosis on digital mammography images is possible. The web based clients are intended for image distribution on either personal computers or mobile devices. JiveX is a client server solution that is mainly implemented in Java. Clients run on personal computers with MS windows operating systems. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines. JiveX is a software only medical device.
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    K Number
    K142750
    Device Name
    JiveX
    Manufacturer
    VISUS TECHNOLOGY TRANSFER GMBH
    Date Cleared
    2015-06-26

    (275 days)

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

    VISUS TECHNOLOGY TRANSFER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. Note: Web-based image distribution and mobile device display are not intended for diagnostic purposes.
    Device Description
    JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. A Communication Server is communicating, storing, and archiving DICOM data and also renders images for the web based image distribution. Fat clients, rich in rendering and image manipulation functionality, are medical diagnostic and viewing workplaces. When using FDA cleared monitors diagnosis on digital mammography images is possible. The web based clients are intended for image distribution on either personal computers or mobile devices. JiveX is a client server solution that is mainly implemented in Java. Clients run on personal computers with MS windows operating systems. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines. JiveX is a software only medical device.
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    K Number
    K053183
    Device Name
    JIVE X SOFTWARE
    Manufacturer
    VISUS TECHNOLOGY TRANSFER GMBH
    Date Cleared
    2006-02-16

    (94 days)

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

    VISUS TECHNOLOGY TRANSFER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information. 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
    Not Found
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