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510(k) Data Aggregation

    K Number
    K022411
    Device Name
    PRECISEPLAN 2.0
    Date Cleared
    2002-09-20

    (58 days)

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

    PRECISION THERAPY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PrecisePLAN® Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAN® provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
    Device Description
    PrecisePLAN® 2.00 is an enhancement to the PrecisePLAN® 1.00, which has previously been cleared for commercial distribution (K002240 8/23/2000). This enhancement to PrecisePLAN® does not raise additional types of safety or effectiveness considerations.
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    K Number
    K002240
    Device Name
    RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
    Date Cleared
    2000-08-23

    (30 days)

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

    PRECISION THERAPY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K992864
    Device Name
    RENDER-PLAN 3-D
    Date Cleared
    1999-09-09

    (15 days)

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

    PRECISION THERAPY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Render-Plan 3-D® is intended to be used for planning the dosimetry of treatments in radiation therapy. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
    Device Description
    The Render-Plan 3-D® is an enhancement to the Render-Plan 3-D 1) (Formerly known as Renner-Plan) which has previously been cleared for (Formerly Known as Renner-Frish) winest (1999). This enhancement to Render-Plan 3-De does not raise additional types of safety of effectiveness considerations.
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