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510(k) Data Aggregation

    K Number
    K980809
    Device Name
    LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
    Manufacturer
    LUMISYS, INC.
    Date Cleared
    1998-05-11

    (69 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMISYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use.
    Device Description
    The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav. The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero. The LUMISCAN 135 uses a solid state laser diode as the beam source. The laser is conditioned by a lens for beam forming and coupled to a fiber. From the fiber, the energy is directed to a scanning galvanometer. The galvanometer has a mirror that is oscillating precisely across the width of the plate and irradiating the plate with laser light. As the light impinges the plate, stored energy from the plate is emitted and collected in an integrating cylinder. The collected light is detected by a photomultiplier, converted to an analog signal which is logarithmically amplified, corrected for spatial variations in the integrating cylinder, and then digitized by an A/D converter.
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    K Number
    K980213
    Device Name
    DI-2000
    Manufacturer
    LUMISYS, INC.
    Date Cleared
    1998-03-17

    (67 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMISYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DI-2000 is intended to utilize a scanner and software interface to digitize either radiology film or computed radiography exposed phosphor plates. DI-2000 is a DICOM 3.0 compliant radiological digitization application. DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class. Supports scanning of films or phosphor plates in batch mode prior to entering patient information. Once scanned, images can be sent to multiple destinations.
    Device Description
    A detailed description of each of all functions is contained in the Functional Requirements Specification, included as Appendix B. The following feature comparison provides an easy way to identify the changes between the initial 510(k) for DICOM Client submitted December 1995, and this addendum for DI-2000.
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