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510(k) Data Aggregation

    K Number
    K024188
    Device Name
    UP-DF500 FILMSTATION DIGITAL FILM IMAGER
    Manufacturer
    SONY MEDICAL SYSTEMS
    Date Cleared
    2003-02-04

    (47 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.
    Device Description
    The Sony UP-DF500 FilmStation™ Digital Film Imager is a general purpose thermal printer and is intended for use as an accessory to a wide variety of medical imaging systems for digitally printing black and white still images with DICOM format. The Sony UP-DF500 is connected to a DICOM network and the image from a compatible medical imaging system is transmitted via the DICOM network.
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    K Number
    K970999
    Device Name
    SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
    Manufacturer
    SONY MEDICAL SYSTEMS
    Date Cleared
    1997-05-20

    (62 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format. The Sony. PCM-100P1MD can be used in hospital settings such as the intensive care unit, central station, and nurse station. Applications include the display of data from electrocardiographs, blood pressure and pulse measurement systems, and computed tomography and other imaging systems.
    Device Description
    The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is a general purpose computer monitor which has been modified for use in medical settings for patient monitoring applications. It will display images received from a computer system and is designed for use with PC-compatible computers.
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    K Number
    K961680
    Device Name
    SONY DKR-700 DIGITAL STILL RECORDER
    Manufacturer
    SONY MEDICAL SYSTEMS
    Date Cleared
    1996-07-03

    (63 days)

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

    SONY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony DKR-700 Digital Still Recorder is intended for use in the recording of video images obtained from medical imaging systems for purposes such as administration, patient record archival storage and education. For example, the DKR-700 Digital Still Recorder can be utilized for recording images acquired by video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes or other systems which produce a compatible video signal.
    Device Description
    The Sony DKR-700 Digital Still Recorder is a general purpose electronic device for digitally recording both color and black and white still images from a variety of analog sources in either a noncompressed or compressed mode to a Sony Magneto Optical (MO) MiniDisc. Recorded images may then be played back from the MO disc and viewed on a standard (analog) video monitor, or may be transmitted via a SCSI interface for importing into a PC/Windows application environment. With the DKR-700, information such as date, image number and image name can be attached to each image. Specific images can then be searched for and retrieved at the user's request. The major components of the Sony DKR-700 Digital Still Recorder are the recorder, the recording media and the DKR-700 plug-in software. The RM-C700 Remote Control Unit and foot switches are optional accessories for external control of the device.
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