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510(k) Data Aggregation

    K Number
    K973959
    Device Name
    OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
    Manufacturer
    OLICON IMAGING SYSTEMS, INC.
    Date Cleared
    1997-12-22

    (67 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLICON IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olicon 02-Workstation and/or PACSView™ Software is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.
    Device Description
    The Olicon 02-Workstation and/or PACSView™ software is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which is used to store, communicate, and view radiological images and data in a digital format. Images are stored and displayed utilizing Intel Pentium processing unit with high resolution monitors.
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    K Number
    K973793
    Device Name
    OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
    Manufacturer
    OLICON IMAGING SYSTEMS, INC.
    Date Cleared
    1997-12-17

    (72 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLICON IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources). The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
    Device Description
    The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.
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