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510(k) Data Aggregation

    K Number
    K241765
    Device Name
    PLANET Onco Dose (3.2)
    Manufacturer
    DOSIsoft SA
    Date Cleared
    2025-03-14

    (267 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOSIsoft SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLANET Onco Dose is a standalone software intended to manage, process, display and analyze anatomical and functional images. It provides tools and functionalities to assist in medical diagnosis and therapy response assessment, to assist in the contouring of regions of interest, and to assist in internal dosimetry computation for radionuclide based therapies. The modalities of these medical imaging systems include CT, MRI, SPECT, PET, XA, planar scintigraphy, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format. PLANET Onco Dose is intended for retrospective determination of dose only and should not be used to deviate from approved radioactive products, product dosing and administration instructions. PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology. PLANET Onco Dose provides the User with the means to segment structures in medical image volumes by providing dedicated delineation, contouring and propagation tools for both tumors and normal tissues (i.e. Regions of Interest (ROI)). PLANET Onco Dose provides tools to display, co-register (rigid and deformable), perform quantification for assessment and response evaluation of patients undergoing a course of oncology treatment. PLANET Onco Dose allows import / export of results (contours and dosimetries) to / from any DICOM compliant system (e.g. Treatment Planning Systems, PACS). PLANET Onco Dose allows to compute in 3D at the radiation doses received by tissues as a result of radionuclide administration. Dose can be computed with or without tissue density correction using two models depending on considered isotopes. PLANET Onco Dose provided the User with the means to perform modeling of absorption and elimination kinetics of Radiopharmaceutical Therapy (RPT). Time-integrated activity and dose rate can be calculated from three kinds of clinical setups involving full 3D image acquisitions, hybrid 2D/3D image acquisitions and single time point approaches. PLANET Onco Dose supports isotopes with beta and gamma contributions. PLANET Onco Dose provides tools for dosimetry comparison for sequential treatments and for dosimetry summation.
    Device Description
    PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, contouring, internal dosimetry computation and therapy response assessment, using molecular imaging modalities. PLANET Onco Dose is a modular software suite composed of three elements: . PLANET - Core System: reviewing, fusion and registration of multi-modal anatomical (computed tomography (CT), magnetic resonance imaging (MRI), X-ray angiography (XA)) and functional (positron emission tomography (PET), single photon emission computed tomography (SPECT), planar scintigraphy) series; . PLANET Onco - Oncology Module: contouring of region of interest, tumor segmentation, quantification, therapy response assessment; . PLANET Dose - Dosimetry Module: pharmacokinetics modeling and internal dosimetry computation for locally regulatory approved pharmaceuticals.
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    K Number
    K231573
    Device Name
    ThinkQA (Edition 2)
    Manufacturer
    DOSIsoft SA
    Date Cleared
    2024-01-18

    (232 days)

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

    DOSIsoft SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThinkQA Edition 2 software is used to verify that the dose distribution calculated by a treatment planning system for external beam radiation therapy is consistent with treatment plan parameters. Based on read-in treatment plan data, ThinkQA Edition 2 re-calculates a dose distribution in a three-dimensional representation of a patient or a phantom and provides dose-volume indicators which compare it to the initial dose distribution calculated by the treatment planning system. ThinkQA Edition 2 is not a treatment planning system. It is a Quality Assurance software only to be used by qualified and trained radiation therapy personnel.
    Device Description
    ThinkQA Edition 2 is a standalone software device used within a radiation therapy clinic which is designed to perform secondary dose calculation based on DICOM RT treatment plan data provided by a treatment planning system. ThinkQA Edition 2 is only meant for quality assurance purpose. It cannot define or transmit any instructions to a delivery device, nor does it control any other medical device. ThinkQA Edition 2 performs dose calculation verifications for radiation therapy plans by doing an independent calculation of dose distribution in a three-dimensional representation of a phantom. Dose distribution is initially calculated by a treatment planning system which is a software tool that allows to define and transmit treatment plan parameters that will further be used for treatment delivery. Based on treatment plan parameters, ThinkQA Edition 2 re-calculates dose distributions using a proprietary Collapsed Cone Convolution algorithm. It uses CT images (real patient anatomy) to perform dose computation with Collapsed Cone Convolution. ThinkQA Edition 2 compares the reference TPS dose distribution with its own calculation using specific indicators such as 3D gamma agreement index on significant volumes. ThinkQA Edition 2 computes Gamma Passing Rate for automatic dose areas and anatomical structures: Planning Target Volumes (PTVs) and Organs at Risk (OARs). Based on these indicators, ThinkQA Edition 2 displays a pass/fail status that informs the user whether or not the acceptance criteria that he has defined are met. The acceptance criteria does not give in any way information that could be used to determine whether or not the treatment plan is clinically relevant. It just evaluates the consistency between treatment plan parameters and the dose distribution computed by the TPS. ThinkQA Edition 2 has been designed to be compatible with radiotherapy adaptative workflows. This includes a number of mandatory features: - User interface design, grouping verifications for adaptive plans under a single primary plan verification; . - . Automatic computation upon reception of DICOM data from the TPS; - Sufficient speed of computation, compatible with adaptive workflow with patient waiting on couch. The performance of ThinkQA Edition 2 makes it suitable for the following photon treatment delivery techniques: Static beams, IMRT Step & Shoot, Dynamic IMRT with fixed gantry and Rotational IMRT (VMAT). In order to guaranty the independence of the secondary dose check, the beam models are not intended to be adjusted to match the user's reference TPS. The user only provides its actual measured dose rate in reference conditions and HU-density conversion table. ThinkQA Edition 2 runs on workstations or virtual machines with Linux CentOS 7 operating system. Its web interface is accessible from any system supporting the specified in chapter ThinkQA Edition 2 web application. ThinkQA Edition 2 is able to communicate with other equipment installed on the network complying with the DICOM and DICOM RT industry standards.
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    K Number
    K112723
    Device Name
    EPIGRAY
    Manufacturer
    DOSISOFT SA
    Date Cleared
    2012-02-08

    (142 days)

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

    DOSISOFT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EPIgray is a software to be used by radiation oncologist and medical physicist to detect errors in the delivery of high energy X-rays during the course of patient treatment. This product verifies if the reconstructed dose, computed by the system, is in agreement with the planned dose given by the treatment planning system. This product uses the measurements performed by an Electronic Portal Imaging Device (EPID). This product uses the prescription computed by the treatment planning system. This product in not used to give a prescription of the radiation therapy.
    Device Description
    EPIgray is comprehensive software that allows the user to perform an in-vivo dosimetry by means of imaging device such as an Electronic Portal Imaging Device (EPID). The product is composed of: EPIgray workstation and In-Vivo Manager tool. Epigray workstation is an extension of an already cleared product: ISOgray planning system (K103146). It uses only two modules of the previously approved system: Information module and Exacor module. In Vivo manager software is a year application intended for in-vivo measurements management. In particular, it allows to retrieve, on a web browser, the result of dose reconstruction by EPIgray workstation based on EPID.
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    K Number
    K103146
    Device Name
    ISOGRAY TREATMENT PLANNING SYSTEM
    Manufacturer
    DOSISOFT SA
    Date Cleared
    2011-03-11

    (137 days)

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

    DOSISOFT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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