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510(k) Data Aggregation

    K Number
    K961160
    Device Name
    UPACS VERSION 1.7
    Manufacturer
    BASE TEN SYSTEMS, INC.
    Date Cleared
    1996-06-11

    (81 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BASE TEN SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    uPACS™ Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environement.
    Device Description
    uPACS Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for capturing, storage, archiving and presentation of video ultrasound images. The system is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output and is cleared for operation and use in the patient environment. uPACS Version 1.7 can also accept images stored on magneto-optical (MO) disks, captured remotely, in video output form.
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    K Number
    K960941
    Device Name
    UPACS
    Manufacturer
    BASE TEN SYSTEMS, INC.
    Date Cleared
    1996-06-03

    (87 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    BASE TEN SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    uPACS™ is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environement.
    Device Description
    uPACS is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output and is cleared for operation and use in the patient environment. In the uPACS standard configuration, an FDA approved ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC). Images captured by the scanner are displayed on the monitor of the PC along with any text that is typed on the PC keyboard. The ultrasound image and patient text data can be stored on a CD-ROM in the PC, and images can be exported to an FDA approved printer by the PC. uPACS enables users to perform the following system functions: - View live images from user provided FDA approved ultrasound scanners or other NTSC or PAL video sources; - Capture single-frame images from ultrasound scanners or other NTSC or PAL video sources; - Obtain text data directly from captured images; - Edit text and image data before permanent storage; - Review stored images on the system and on CD-ROM; - Display up to four images at a time for review; - Place notations directly on images; - Archive images using CD-ROM; - Export images to diskette and user provided printer(s); - Provide a means for user training and proficiency demonstration; - Assign security privileges to specific users in accordance with clinical access criteria.
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