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510(k) Data Aggregation
K Number
K211034Device Name
Corvus Radiation Therapy Planning System
Manufacturer
Best Nomos
Date Cleared
2021-05-06
(29 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Best Nomos
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
Device Description
CORVUS is a semi-automatic planning system: For forward planning, the system allows the user to design a treatment plan. For IMRT, rather than simply verifying a user-designed plan, the system itself suggests a plan. A clinician then reviews and approves the plan.
CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution.
Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.
The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan.
CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them user-selectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.
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K Number
K201350Device Name
CORVUS
Manufacturer
Best Nomos
Date Cleared
2020-09-20
(122 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Best Nomos
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
Device Description
CORVUS is a semi-automatic planning system: For forward planning, the system allows the user to design a treatment plan. For IMRT, rather than simply verifying a user-designed plan, the system itself suggests a plan. A clinician then reviews and approves the plan.
CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution.
Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.
The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan.
CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them user-selectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.
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K Number
K170345Device Name
SOFTDISO
Manufacturer
Best Nomos
Date Cleared
2017-10-27
(266 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Best Nomos
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only.
SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
Device Description
SOFTDISO software permit an IN-VIVO dosimetric analysis (IVD) in patient for 3DCRT, IMRT and VMAT beams using a Si-EPID portal systems.
The dosimetric analysis consists of two tests elaboration, dose reconstruction in the isocenter point and EPID images y-analysis. In case of out of tolerance levels, the system is capable of underline the right type of quality control useful to remove the causes of discrepancy.
SOFTDISO software is based on the usage of generalized correlation factors between transit signals measured by EPID and doses measured in water equivalent solid phantom, along the beam central axis.
SOFTDISO software uses generalized functions taken from measurements of 70 beams of Varian, Elekta and Siemens linacs. So only a small set of dosimetric measurements must be performed by the user for the software commissioning, and some of those measurements are already performed during the linac's beams calibration. In particular some of the measurements that the user performs include calculating the beam dose in cGy/UM in reference conditions (field 10.10 cm2 at drif =10 cm depth), the beam quality indicator (TPR20, 10) and the attenuation factor WF for wedged beams. The user also performs a measure of the EPID signal in reference condition (field 10.10 cm2 at SED distance) for EPID calibration.
SOFTDISO software can use information coming from record and verify systems through DICOM and DICOM-RT protocols. DICOM protocol is used for transferring images from CT and from EPID and the DICOM-RT protocol is used for transferring information related to the TPS system.
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K Number
K151469Device Name
CORVUS Radiation Therapy Planning System
Manufacturer
BEST NOMOS
Date Cleared
2015-11-25
(177 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
BEST NOMOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
Device Description
CORVUS is a semi-automatic planning system: rather than simply verifying a user-designed plan, the system itself suggests a plan. A clinician then reviews and approves the plan.
CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution.
Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.
The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan.
CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them user-selectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.
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K Number
K100092Device Name
CORVUS RADIATION THERAPY PLANNING SYSTEM
Manufacturer
BEST NOMOS
Date Cleared
2010-02-23
(41 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
BEST NOMOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: CORVUS is intended for use as a planning tool for conformal radiation therapy. Using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. CORVUS is intended only to suggest a delivery plan. It is the physician's responsibility to verify that the dose distributions which would result from plan implementation are appropriate for a particular patient. The CORVUS system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy. The modulating device can be the NOMOS MIMIC, nomosSTAT MLC, or a supported MLC. CORVUS produces radiation fields which are modulated to conform to the projected tumor volume plus margins. The system tries to achieve target goals while sparing sensitive structures.
Indications for Use: The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist. The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
Device Description
CORVUS is a semi-automatic planning system: rather than simply verifying a userdesigned plan, the system itself suggests a plan. A clinician then reviews and approves the plan. CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution. Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent. The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan. CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them userselectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.
Ask a Question
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