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510(k) Data Aggregation

    K Number
    K983768
    Device Name
    MODIFICATION TO GAMMA GUIDANCE SYSTEM
    Manufacturer
    RADIATION MONITORING DEVICES, INC.
    Date Cleared
    1999-07-02

    (249 days)

    Product Code
    IZD
    Regulation Number
    892.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIATION MONITORING DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical , laparoscopic or thoracoscopic surgical procedures.
    Device Description
    The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-held sensor probes, a counting unit, and a cable interconnecting the two.
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    K Number
    K961321
    Device Name
    GAMMA GUIDANCE SYSTEM
    Manufacturer
    RADIATION MONITORING DEVICES, INC.
    Date Cleared
    1997-02-10

    (311 days)

    Product Code
    IZD
    Regulation Number
    892.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIATION MONITORING DEVICES, INC.

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