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510(k) Data Aggregation

    K Number
    K000052
    Device Name
    X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
    Manufacturer
    DYNARAD CORP.
    Date Cleared
    2000-02-10

    (34 days)

    Product Code
    ITY
    Regulation Number
    892.1760
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNARAD CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981267
    Device Name
    FACTS MONOBLOCK
    Manufacturer
    DYNARAD CORP.
    Date Cleared
    1998-05-06

    (29 days)

    Product Code
    IZX, ITY, IZO
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNARAD CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General Purpose Fluoroscope Applications
    Device Description
    Not Found
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    K Number
    K973833
    Device Name
    CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
    Manufacturer
    DYNARAD CORP.
    Date Cleared
    1997-12-30

    (84 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNARAD CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DynaRad NEO is a General Purpose Mobile X-Ray System that is specifically optimized to operate within the Neo Natal environment. The maximum output is 70 kVp at 50 mA from a 115/220 V outlet
    Device Description
    NEO Mobile X-Ray System
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