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510(k) Data Aggregation

    K Number
    K991815
    Device Name
    EXPLORER 3D
    Manufacturer
    OUR SCIENTIFIC INTL., INC.
    Date Cleared
    1999-08-13

    (78 days)

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

    OUR SCIENTIFIC INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
    Device Description
    Not Found
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    K Number
    K970647
    Device Name
    OUR ROTATING GAMMA SYSTEM
    Manufacturer
    OUR SCIENTIFIC INTL., INC.
    Date Cleared
    1997-05-20

    (89 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    OUR SCIENTIFIC INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OUR Rotafing Gamma System is a teletherapy device intended to be used for the stereotactic irradiation of intracranial structures.
    Device Description
    The OUR Rotating Gamma System is a teletherapy device which contains 30 60 Co sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built-in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the 600 y-ray beams during treatment, 30 nonoverlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The y-ray treatment unit, b) the stereotactic localization system, and c) the treatment planning system. To ensure mechanical safety, the system uses redundant limit switches to detect the positions of the doors, and the couch. Low torque motors are used such that all motions can be stopped by one hand. Electrical safety is ensured by use 24VDC power in the entire treatment unit with multiple current limiting breakers. Redundant timing devices are used for treatment timing accuracy. The novel radiation shutter reduces transient radiation exposure to patient's normal structures and adds radiation safety.
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