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510(k) Data Aggregation

    K Number
    K992586
    Device Name
    KONICA LASER IMAGER, DRYPRO MODEL 722
    Manufacturer
    KONICA CORP.
    Date Cleared
    1999-10-29

    (88 days)

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

    KONICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konica Laser Imager DRYPRO model 722 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.
    Device Description
    Konica Laser Imager DRYPRO model 722 is a laser imager
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    K Number
    K990359
    Device Name
    KONICA DIRECT DIGITIZER, MODEL DD-341
    Manufacturer
    KONICA CORP.
    Date Cleared
    1999-08-17

    (193 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konica Direct Digitizer (Computed Radiography Device) Model DD-341/Regius 150 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
    Device Description
    Konica Direct Digitizer, Model DD-341/Regius 150 is a Computed Radiography Device.
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    K Number
    K980873
    Device Name
    KONICA DIRECT DIGITIZER REGIUS MODEL 330
    Manufacturer
    KONICA CORP.
    Date Cleared
    1998-06-19

    (105 days)

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

    KONICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reading, processing, displaying and printing X-ray images from exposed photostimulable phosphor plates.
    Device Description
    Not Found
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