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510(k) Data Aggregation

    K Number
    K982937
    Device Name
    MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
    Manufacturer
    VICTOREEN, INC.
    Date Cleared
    1998-11-19

    (90 days)

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

    VICTOREEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines.
    Device Description
    The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case.
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    K Number
    K974112
    Device Name
    VACUDAP, MODEL 2000, 2001
    Manufacturer
    VICTOREEN, INC.
    Date Cleared
    1998-01-29

    (90 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    VICTOREEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nuclear Associates VacuDAP - Model 2000, 2001 is intended to measure the radiation output of diagnostic X-ray generating machines during imaging of patients in both radiography and fluoroscopy. The instrument measures and displays Dose Area Product, a parameter that can be related to patient dose by a Medical Physicist. The Dose Area Product measurement includes the influence of dose rate, screening time and used field quantity variables. The instrument accumulates Dose Area Product values until manually reset by the user.
    Device Description
    The basic unit VacuDAP 2000 consists of the square ionization chamber and the chamber electronics including the high voltage generation, amplifier, microcontroller and a 8-digit display. These components are designed as a compact unit. The VacuDAP 2001 is completed display. These control (terminal) which makes it possible to operate from everywhere. Optional a printer is available. The X-ray generates an electric charge in the ionization chamber which is measured by the electronic evaluator as chamber current. The microcontroller calculate the dose area product and dose area product rate including the factor of the chamber. The results are transmitted to the serial interface on request of the terminal microcontroller. The measuring operation is working irrespective of the data displayed and is cumulating until the electronic evaluator is reset.
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    K Number
    K973960
    Device Name
    MODEL 37-185
    Manufacturer
    VICTOREEN, INC.
    Date Cleared
    1998-01-14

    (90 days)

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

    VICTOREEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 37-185 is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics.
    Device Description
    The product consists of two main parts; the readout module, and the scanner (data acquisition) module. The readout module is located outside the treatment room while the scanner is positioned on the treatment couch in such a manner as to allow the detectors to transverse the radiation beam as determined by the operator. The readout and the scanner are connected via a single 25 meter (75 foot) shielded cable. The readout contains a LCD (Liquid Crystal Display) and 8 softkeys providing the operator interface. The readout also includes the microprocessor system, memory, printer interface and computer interface. Connections are provided for the power supply, parallel printer, computer RS-232 interface and the scanner cable. The scanner module contains a stepper motor and a transport mechanism that moves a light detecting diode and a radiation detecting diode 50 cm, in a straight line to obtain a beam or light field profile during a measurement cycle. There is a fixed radiation detecting diode located in the center of the scanner which acts as a reference to null out any fluctuations in the amplitude of the radiation beam (as a function of time). The stepper motor controller and detector pre-amplifiers are also housed in the scanner assembly. The product includes a separate leveling mechanism to level the scanner module and rotate it 90 degrees.
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    K Number
    K964952
    Device Name
    VERIDOSE V (FIVE), MODEL NUMBER 37-705
    Manufacturer
    VICTOREEN, INC.
    Date Cleared
    1997-07-21

    (223 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    VICTOREEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device provides integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy. The diodes produce a current directly proportional to the ionizing radiation to which they are exposed. The diodes are connected to this readout device. The purpose of the combination of the diodes and this product are to measure ionizing radiation independently at various points of interest. The VeriDose V is intended for use by persons responsible for the proper interpretation of its readings and observing the appropiate safety procedures in the presence of radiation. The Veridose V (Five) - Model Number 37-705 is used to provide integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy.
    Device Description
    The product is a five channel diode dosimeter. The device will measure and display real time dose rate or integrated dose on up to 5 diodes simultaneously. The features include a keyboard, an ON / OFF switch, a power input connector (12VDC), 5 BNC connectors for diode inputs, a RS-232 connector, and a parallel printer port connector. Up to 21 sets of calibration data can be acquired, stored, and selected for use. Calibration and patient data is transmitted to a printer or the RS-232 port.
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    K Number
    K964785
    Device Name
    VERIDOSE DIODES
    Manufacturer
    VICTOREEN, INC.
    Date Cleared
    1997-06-13

    (196 days)

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

    VICTOREEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These diodes are used to provide dose verification and quality assurance for paţients undergoing radiation therapy.
    Device Description
    The product consists of a waterproof color coded molded plastic hemisphere containing the appropriate buildup material and a radiation sensitive diode attached to a coaxial cable. A BNC connector is supplied for connection to a readout device.
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    K Number
    K971382
    Device Name
    PRONE BREAST POSITIONING BOARD, MODEL #37-018
    Manufacturer
    VICTOREEN, INC.
    Date Cleared
    1997-06-06

    (84 days)

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

    VICTOREEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.
    Device Description
    The Prone Breast Positioning Board is a linear accelerator couch-mounted platform which enables the breast to hang in a comfortable, gravity-dependent fashion for treatment with opposed tangential photon beams.
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