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510(k) Data Aggregation

    K Number
    K062817
    Device Name
    PTW DAVID IMRT QC VERIFICATION SYSTEM
    Manufacturer
    PTW-NEW YORK CORP.
    Date Cleared
    2006-11-22

    (63 days)

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

    PTW-NEW YORK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PTW DAVID is a transparent multiple wire or multiple segment ionization chamber with attached electronics. It is intended to be used as an IMRT QC check device to make verification measurements and provide documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation bear data, consistency, over time as part of a quality assurance program.
    Device Description
    The PTW DAVID system MLC-29 is a transparent, segmented, multi-wire ionization chamber with 37 wires or segments. It is designed for operation in medical hierar accelerators with 29 multi-leaf collimator pairs. The PTW DAVID system MLC-80 is a transparent, segmented, multi-wire ionization chamber with 40 wires or segments. It is designed for operation in medical hiear accelerators with 40 multi-leaf collimator pairs. The PTW DAVID system MLC-120 and MLC-80 are transparent, segmented, multiwire ionization chamber with 80 and 40 wires or segments. They are desioned for operation in medical linear accelerators with 60 or 40 multi-leaf collimator pairs. The software for the PTW DAVID is for recording or logging measurement data only.
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    K Number
    K010705
    Device Name
    OPTIDOS
    Manufacturer
    PTW-NEW YORK CORP.
    Date Cleared
    2003-03-11

    (732 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    PTW-NEW YORK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010916
    Device Name
    PTW DOSIMETRY DIODE, T60008
    Manufacturer
    PTW-NEW YORK CORP.
    Date Cleared
    2001-06-20

    (85 days)

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

    PTW-NEW YORK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972211
    Device Name
    MULTIDOS, QC6PLUS
    Manufacturer
    PTW-NEW YORK CORP.
    Date Cleared
    1997-09-10

    (90 days)

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

    PTW-NEW YORK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PTW T10004 MULTIDOS is a multiple-purpose, multiple-channel electrometer inlended to perform a range of measuring tasks in radiation therapy. As a stand alone dosemeter, MULTIDOS is intended to be used to measure the dose delivered to a palient during a radiation therapy treatment. Dose measurements during treatment may be accomplished by using suitable ionization chambers or solid state detectors and are used to compare and to verify treatment dose to prescribed dose. When connected to the optional QC6PLUS, MULTIDOS is intended to be used to measure the beam characteristics of radiation therapy treatment machines. Data acquired with the MULTIDOS and the QC6PLUS is used to compile radiation beam data over time as part of a quality assurance program. High quality dosimetry devices like the PTW T10004 MULTIDOS and the optional T42007 QC6PLUS make it possible to routinely measure, record, document and verify therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision. High quality multiple purpose dosimetry devices are essential if accurate data from trealment machines that produce therapeutic amounts of ionizing radiation are to be properly monitored.
    Device Description
    The PTW T10004 MULTIDOS is a field class multiple-purpose multiple-channel electrometer. This device is designed to accurately measure dose, dose rate, charge, and current for photons and electrons in the therapeutic energy ranges. MULTIDOS may be configured as a stand alone 2, 6, or 12 channel electrometer and can be used with suitable ionization chambers and solid state detectors. The PTW T42007 QC6PLUS is a therapy beam constancy device which may configured with 6 or 10 individual 0.54 cm³ ionization chambers orthogonally arranged and imbedded in a 5 cm thick PMMA slab. When the QC6PLUS is connected to MULTIDOS, therapy beam parameters like flatness, symmetry, energy stability, and central beam dose are easily monitored.
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    K Number
    K972212
    Device Name
    0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
    Manufacturer
    PTW-NEW YORK CORP.
    Date Cleared
    1997-09-10

    (90 days)

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

    PTW-NEW YORK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PTW T31006 and T31007 Pinpoint type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.
    Device Description
    The PTW T31006 and T31007 are classical waterproof ionization chambers that differ only in the lengths of their respective active volumes. The T31006 is a 0.015 cc ionization chamber with a 5 mm active length and the T31007 is a 0.005 cc ionization chamber with a 2 mm active length. Both chamber volumes are open to the atmosphere, they are waterproof, and they are vented via their connectors. These chambers are constructed of precisely the same materials, are available with a 1 m or 10 m cable for connection to an electrometer, and may be terminated in a variety of standard electrometer connectors (BNT, TNC, PTW M, or BNC banana.
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    K Number
    K961208
    Device Name
    0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER
    Manufacturer
    PTW-NEW YORK CORP.
    Date Cleared
    1996-06-17

    (83 days)

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

    PTW-NEW YORK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PTW T30004, T30005, T30001 and T30002 0.6 cc Farmer type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.
    Device Description
    The PTW T30004 and T30005 are classical 0.6 cc Farmer type ionization chambers. These chambers differ only in the type of material their respected thimbles are made of. The T30004 has a graphite thimble and an aluminum stem and the T30005 has a solid water thimble and an aluminum stem. The chambers can be thimble vented, which is not waterproof, or connector vented, which is water proof. Both chambers offer 1 or 10 meter cables for connection to an electrometer, and a variety of standard electrometer connectors (BNT, TNC, M, BNC banana). The connector vented version of the PTW T30001 and T30002 Farmer type ionization chambers are simply a waterproof version of the thimble vented chambers that were cleared to market by the FDA under K951764. The Farmer type ionization chamber, when connected to an appropriate electrometer like the PTW-UNYODS. K951764, is used to collect beam data from radiation therapy treatment machines.
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