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510(k) Data Aggregation

    K Number
    K002608
    Device Name
    INVAC
    Date Cleared
    2000-11-16

    (87 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUNCAN HYND ASSOCIATES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K981911
    Device Name
    PROFA
    Date Cleared
    1998-11-12

    (164 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUNCAN HYND ASSOCIATES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For radiation therapy, patient/body contouring, virtual simulation and verification of the patient's treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system is portable and can be used in the radiotherapy room.
    Device Description
    PROFA an Optical Patient Contouring Device
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