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510(k) Data Aggregation

    K Number
    K033013
    Device Name
    MDIFICATION TO MEDIPRIME
    Manufacturer
    ALGOTEC SYSTEMS, LTD.
    Date Cleared
    2003-11-25

    (60 days)

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

    ALGOTEC SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
    Device Description
    The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf PCs running Windows 2000/XP operating systems and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Angiography MIP, Vessel Tracking and Tissue Definition.
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    K Number
    K023936
    Device Name
    MODIFICATION TO MEDIPRIME
    Manufacturer
    ALGOTEC SYSTEMS, LTD.
    Date Cleared
    2002-12-20

    (24 days)

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

    ALGOTEC SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
    Device Description
    The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).
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    K Number
    K002894
    Device Name
    MEDIPRIME
    Manufacturer
    ALGOTEC SYSTEMS, LTD.
    Date Cleared
    2000-12-05

    (78 days)

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

    ALGOTEC SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980648
    Device Name
    PRO VISION
    Manufacturer
    ALGOTEC SYSTEMS, LTD.
    Date Cleared
    1998-07-20

    (151 days)

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

    ALGOTEC SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device. ProVision functions include :Archiving, displaying, manipulation, filming, 2and 3-dimensional processing. ProVision employs a graphical multi -Window, icon and mouse driven user interface. It is designed to ensure maximum flexibility on the one hand, and intuitive operation on the other.
    Device Description
    The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological images. It is based on off-the shelf Silicon Graphics UNIX based computers that comply with the accepted international standards for computer systems. The systems also comprises software developed and validated by Algotec Systems Ltd.
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    K Number
    K954678
    Device Name
    PRO VISION
    Manufacturer
    ALGOTEC SYSTEMS, LTD.
    Date Cleared
    1996-01-05

    (87 days)

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

    ALGOTEC SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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