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510(k) Data Aggregation

    K Number
    K153014
    Device Name
    Mobius3D
    Manufacturer
    MOBIUS MEDICAL SYSTEMS, LP
    Date Cleared
    2016-04-29

    (197 days)

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

    MOBIUS MEDICAL SYSTEMS, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography). Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
    Device Description
    Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients. Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm. Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features. Compared to the previously cleared Mobius3D v 1.3.2 (K140660), Mobius3D v 2.0.0 contains the additional intended use of performing quality assurance of a patient's alignment and anatomy analysis. This analysis is based on comparison of Cone Beam Computed Tomography (CBCT) images taken immediately before treatment to the images used for treatment planning, which are typically acquired using standard Computed Tomography (CT). This analysis is presented to the end user in an add-on software module within Mobius3D called CBCT Checks.
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    K Number
    K141230
    Device Name
    DOSELAB PRO
    Manufacturer
    MOBIUS MEDICAL SYSTEMS, LP
    Date Cleared
    2014-08-27

    (106 days)

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

    MOBIUS MEDICAL SYSTEMS, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DoseLab Pro is quality assurance software intended to be used as part of a dosimetry verification system for linear accelerators. It can be used to import radiation-exposed images from scanned film, other measurement devices, and treatment planning systems to display differences between measured and calculated dose distributions.
    Device Description
    DoseLab Pro is a software-only device that uses image analysis to perform radiation oncology quality assurance (QA) as part of a dosimetry verification system. Images are useful in radiation oncology QA because they can be analyzed qualitatively by viewing them and quantitatively using mathematical routines on the data that composes them. A variety of data sets can be analyzed as images in DoseLab Pro. They include radiation dose distributions calculated by treatment planning systems, measured dose distributions from arrays (diode and ion chamber), and radiation-exposed film images. DoseLab Pro uses numerous built-in image analysis routines that have been developed to perform the tests and meet the standards of the medical physics QA community. In particular, these tools were designed to specifically support completing dose comparisons. Dose comparisons are made between two, two-dimensional images containing radiation dose and spatial information. The first image is exported from the dose calculation of a patient-specific computed treatment plan from treatment planning software, while the second image is the measured dose from delivery of that plan captured by film or a measurement array. DoseLab Pro assists in aligning the images spatially before performing several different comparisons including Gamma analysis and normalization. DoseLab Pro additionally contains tools for image editing, film image import, and film calibration. It is important to note that while DoseLab Pro operates in the field of radiation therapy, it is neither a radiation delivery device (e.q. a linear accelerator), nor is it a treatment planning system (TPS). DoseLab Pro is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, DoseLab Pro never comes into contact with patients.
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    K Number
    K140660
    Device Name
    MOBIUS3D
    Manufacturer
    MOBIUS MEDICAL SYSTEMS, LP
    Date Cleared
    2014-06-24

    (102 days)

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

    MOBIUS MEDICAL SYSTEMS, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
    Device Description
    Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients. Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm. Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.
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