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510(k) Data Aggregation

    K Number
    K231041
    Device Name
    JiveX (Model Number / Release: 5.4)
    Date Cleared
    2023-07-14

    (93 days)

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

    VISUS Health IT GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 or non-lossy compressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
    Device Description
    JiveX is a PACS software, with a Moderate level of concern. A Communication Server is communicating, storing, converting, and archiving images, documents and signal data via DICOM. HL7 and proprietary interfaces. It also renders images for the web-based image distribution. The fat clients can be used as workstations for medical reading and reporting. They provide extensive functions for image display and image processing. The reporting of digital mammography images is also supported. The web-based clients are mainly intended for image distribution on personal computers and mobile devices. They offer less functions than the fat clients. As far as the functions allow for it, the web clients can also be used for reading and reporting on personal computers.
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    K Number
    K212321
    Device Name
    JiveX (Model Number / Release: 5.3)
    Date Cleared
    2021-09-23

    (59 days)

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

    Visus Health IT GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 or non-lossy compressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
    Device Description
    JiveX is a PACS software, with a Moderate level of concern. A Communication Server is communicating, storing, and archiving images, documents and signal data via DICOM. HL7 and proprietary interfaces. It also renders images for the web-based image distribution. The fat clients can be used as workstations for medical reading and reporting. They provide extensive functions for image display and image processing. The reporting of digital mammography images is also supported. The web-based clients are mainly intended for image distribution on personal computers and mobile devices. They offer less functions than the fat clients. As far as the functions allow for it, the web clients can also be used for reading and reporting on personal computers.
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    K Number
    K200703
    Device Name
    JiveX
    Date Cleared
    2020-04-14

    (27 days)

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

    Visus Health IT GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is 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. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes. JiveX is a PACS software, with a Moderate level of concern. A Communication Server is communicating, storing, and archiving images, documents and signal data via DICOM, HL7 and proprietary interfaces. It also renders images for the webbased image distribution. The fat clients can be used as workstations for medical reading and reporting. They provide extensive functionality for image display and image processing. The reporting of digital mammography images is also supported. The web-based clients are mainly intended for image distribution on personal computers and mobile devices. They offer less functionality than the fat clients. As far as the functionality allows for it, the web clients can also be used for reading and reporting on personal computers. JiveX in release 5.0.6 (K181964) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware.
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    K Number
    K181964
    Device Name
    JiveX
    Date Cleared
    2018-10-23

    (92 days)

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

    Visus Health IT GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is 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. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes. 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 in the first place. As far as the limited functionality of the web clients allows for it, the web clients may also be used on personal computers for reading and reporting. JiveX in release 5.0 (K162008) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware. The most notable enhancements are: - 1. JiveX Web has been qualified for reading. As far as the limited functionality of JiveX Web allows for it, it may now be used for reading and reporting. Nevertheless the main use case of the web clients remains image distribution. - 2. Enhancements of the viewing clients include: - Optimized display of temporal series of 3D volumes: streamlined navigation to the same location in space at another point in time. - Curved MPR: multi planar reconstruction of views along a path curved in 3D - Support of presentation states in the web clients. - 3. Enhancements of the Healthcare Content Management (HCM) infrastructure include: - refinement of the access privileges down to individual documents. - Handling of patient IDs from different institutions throughout the system using assigning authority IDs and master patient IDs. - Improvements of pre-fetching designed for use cases where image data is stored in 3rd party PACS. - The new module JiveX Signature Gateway provides an interface to 3rd party signature servers. It allows to electronically sign documents imported into the HCM system and to validate electronic signatures. - The new module JiveX WADO Gateway provides a web interface using the standard DICOM WADO-URI protocol. It allows to retrieve images or documents based on instance UID or the document ID.
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