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510(k) Data Aggregation

    K Number
    K974423
    Device Name
    ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
    Manufacturer
    STERLING DIAGNOSTIC IMAGING, INC.
    Date Cleared
    1997-12-22

    (28 days)

    Product Code
    EAM
    Regulation Number
    892.1960
    Why did this record match?
    Product Code :

    EAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
    Device Description
    Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet activated rare earth intensifying screens. The phosphor is niobium activated lutetium tantalate.
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    K Number
    K963913
    Device Name
    MD100 & MM150
    Manufacturer
    KONICA MEDICAL CORP.
    Date Cleared
    1997-10-08

    (373 days)

    Product Code
    EAM
    Regulation Number
    892.1960
    Why did this record match?
    Product Code :

    EAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accessory to a cassette to convert X-Ray energy into light energy.
    Device Description
    Not Found
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    K Number
    K954161
    Device Name
    JPI INTENSIFYING SCREEN
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    1996-02-02

    (150 days)

    Product Code
    EAM
    Regulation Number
    892.1960
    Why did this record match?
    Product Code :

    EAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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