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510(k) Data Aggregation

    K Number
    K984241
    Device Name
    ROCS ULTRASEED
    Manufacturer
    RADIATION ONCOLOGY COMPUTER SYSTEMS
    Date Cleared
    1999-05-12

    (166 days)

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

    RADIATION ONCOLOGY COMPUTER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ROCS ULTRASEED™ (Prostate Ultrasound-guided Brachytherapy Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations for prostate ultrasound-guided brachytherapy to be submitted for independent clinical review and judgment. The goal of this system is to provide a tool that will provide consistent results using well documented algorithms. This system does not provide direct or indirect control over any treatment delivery device or system in any form. The device only provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan and for documenting the actual implant. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
    Device Description
    ROCS Ultraseed is software that executes well known and documented algorithms to produce radiation dose estimations for prostate ultrasound-guided brachytherapy. All data is user controlled and is in a table look-up format. Information is presented graphically on CRT screens and in hardcopy reports. The software is designed to run on a PC platform utilizing the Microsoft® Windows® operating systems. All dates are four digit numbers so the system is able to handle the year 2000.
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    K Number
    K982791
    Device Name
    ROCS TPS
    Manufacturer
    RADIATION ONCOLOGY COMPUTER SYSTEMS
    Date Cleared
    1998-12-30

    (142 days)

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

    RADIATION ONCOLOGY COMPUTER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ROCS TPS (Radiation Therapy Treatment Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist
    Device Description
    ROCS treatment planning system is a collection of software modules that execute well known and documented algorithms to produce radiation dose estimations. All data is user controlled and is in a table look-up format. Information is presented graphically on CRT screens and in hardcopy reports. Various models are available based upon the specific features desired by the customer (e.g., asymmetric jaws, electron pencil beam calculations, etc.) to best meet their clinical needs. The software is designed to run on a PC platform utilizing the Microsoft® Windows NT® operating system. ROCS treatment planning system has been designed to be upgradable in both software features and hardware. All dates are four digit numbers so the system is able to handle the year 2000.
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