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510(k) Data Aggregation

    K Number
    K991282
    Device Name
    COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
    Manufacturer
    SEIKO INSTRUMENTS USA, INC.
    Date Cleared
    1999-06-30

    (77 days)

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

    SEIKO INSTRUMENTS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
    Device Description
    The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.
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    K Number
    K971760
    Device Name
    COLORPOINT OR PROFESSIONAL COLORPOINT
    Manufacturer
    SEIKO INSTRUMENTS USA, INC.
    Date Cleared
    1997-10-01

    (142 days)

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

    SEIKO INSTRUMENTS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for producing full-bleed thermal wax prints in various sizes from medical image signal inputs.
    Device Description
    Color point 820 PS, 830 Ps and Professional Colorpoint 2 Model 04.
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