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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
    K191944
    Device Name
    MU2net
    Manufacturer
    DOSIsoft
    Date Cleared
    2019-10-24

    (94 days)

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

    DOSIsoft

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment plan verification System by double Monitor Units calculation and in vivo verifications management. MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets. It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions. MU2net is dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.
    Device Description
    MU2net is a standalone software designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems. MU2net is also designed to manage in vivo measurements performed by skin dose detectors (diode in vivo dosimetry).
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    K Number
    K182966
    Device Name
    PLANET Onco Dose
    Manufacturer
    DOSIsoft
    Date Cleared
    2019-03-06

    (131 days)

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

    DOSIsoft

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medical medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy. PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology. The medical modalities of these medical imaging systems include CT. MRI, SPECT, PET. XA, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format. 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 (including deformable registration), compute Standardized Uptake Value (SUV) and import / export results (contours and dosimetries) to / from Treatment Planning Systems (TPS) and PACS devices for assessment and response of patients undergoing a course of oncology treatment. PLANET Onco Dose provides the user with the means to assist in the assessment quantification of radiation doses received by tissues as a result of administering a radionuclide (e.g. Permanent Yttrium-90 microsphere implants). PLANET Onco Dose provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 (Y90) microspheres: - 3D liver-lung shunt assessment; - Local Deposition Model; - Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1]: - Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series; - Compatible with PET images acquired with another radioisotope instead of Y90 when Y90 acquisitions are not supported by the scanner (correction of branching ratio and decay parameters). For Y90 microspheres. PLANET Onco Dose cannot be used to prescribe the radionuclide activity to be administered to the patient for the therapy. The user has to provide the parameters (e.g. activity) in order for PLANET Onco Dose to estimate the radiation doses that the tissues received as a result of the administration. PLANET Onco Dose should only be used for the retrospective determination of dose and not for the case where is a need for retreatment using Y90 microspheres.
    Device Description
    PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities. PLANET Onco Dose is a modular software suite composed of three elements: - PLANET: Core System: license controller, reviewing of multi-modal molecular image series -(PET/CT, SPECT/CT, PET/MRI, SPECT/MRI): fusion and registration; - -PLANET Onco: Oncology Module: contouring of region of interest, turnor segmentation, tumoral activity monitoring, therapy response assessment; - -PLANET Dose: Dosimetry Module: internal dosimetry computation for the Targeted Radionuclide Therapy (TRT).
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    K Number
    K180106
    Device Name
    ThinkQA
    Manufacturer
    DOSIsoft
    Date Cleared
    2018-03-13

    (56 days)

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

    DOSIsoft

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended. The Epibeam module contained in ThinkQA is intended to be used as follows: Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification. The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user. Epibeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data. Epibeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy). Epibeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
    Device Description
    ThinkQA is a modular software suite composed of the module Epibeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams. The EPIbeam verification module integrated to the ThinkOA software platform is a Quality Assurance tool in external beam radiation therapy, used in combination with the electronic portal imaging device (EPID) and dedicated to the irradiation beam pre-treatment verifications, particularly for IMRT and VMAT techniques. EPIbeam principle is based on the comparison of two images expressed in terms of absolute dose: on the one hand, a RT Plan defined in the TPS is used for the acquisition of a real portal image (test image) with the EPID directly irradiated (without attenuating medium); on the same RT Plan is used to compute a theoretical portal image (reference image). Specific models and algorithms are applied to express both images in the same absolute dose terms. The dose images obtained from the same RT Plan, one by the conversion model of the acquired raw EPID images and the other by the prediction model, can be quantitatively compared through dose difference mappings or 2D gamma-index. Both models are based on dosimetric data provided from the TPS.
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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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