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510(k) Data Aggregation
K Number
K233236Device Name
Radiance V5
Manufacturer
GMV Soluciones Globales Internet S.A.U.
Date Cleared
2024-05-17
(232 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
GMV Soluciones Globales Internet S.A.U.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Radiance V5 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V5 shall be clinically qualified radiation therapy staff trained in using the system.
Device Description
Radiance V5 is a treatment simulation tool with faster Monte-Carlo simulation, multi-modal planning based on modern imaging standard for intraoperative radiotherapy (IORT). A software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest , deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing alternative plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
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K Number
K171885Device Name
Radiance V4
Manufacturer
GMV Soluciones Globales Internet S.A.U.
Date Cleared
2017-07-25
(29 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
GMV Soluciones Globales Internet S.A.U.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Radiance V4 is a software system intented for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
Device Description
Radiance V4 is a planning tool for intraoperative radiotherapy (IORT), an application that provides a simulation of the dose distribution according to the parameters involved in the procedure. These parameters in IORT include the geometry of the applicator, its orientation and position with respect to the patient and IORT device parameters.
Radiance V4 is designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The user can adjust parameters to achieve a predicted outcome, rather than make a decision intra-operatively. The created treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
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K Number
K153368Device Name
Radiance V3
Manufacturer
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
Date Cleared
2016-02-16
(85 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Radiance V3 is a software system intented for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.
Device Description
Radiance V3 is a treatment planning system, that is, a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing alternative plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
Radiance V3 improvements over Radiance V2 (K133655) are:
- A Hybrid Monte Carlo dose computation algorithm for photons for the ● INTRABEAM.
- . A beam modeling tool which models and verifies the treatment unit model with measurements for the INTRABEAM.
- . An improved DICOM interface including PACS query&retrieve functionality. Storage SCP and DICOM.RT Structures and Dose exportation.
The list of compatible IOERT/IORT devices are:
- Intrabeam (a Carl Zeiss product) ●
- . NOVAC7 and NOVAC11 (a SIT product)
- . LIAC10 and LIAC12 (a SIT product)
- MOBETRON (an IntraOp Medical product)
- . Conventional LINACs with adapted cylindrical IOERT applicators (telescopic or fixed ones).
Radiance V3 has been tested with Elekta/Precise and Varian/21EX LINACs with particular IOERT cylindrical telescopic applicators.
Characteristics of radiance include:
- 1. Image manipulation and visualization
- 2. IORT applicator simulation
- 3. Contouring manual and interpolation tools
- 4. Dose calculation algorithms, including:
- a. For Intrabeam, Dose Painting for a fast (a few seconds) interpolation of PDD around the applicator or Hybrid Monte Carlo for a good combination of computation time (a few minutes) and accuracy.
- b. For IOERT, pencil beam for a fast (less than one minute) calculation of the dose or Monte Carlo for a good combination of computation time (between 1-10 minutes in most of the cases) and accuracy.
- 5. Reporting.
- 6. DICOM & DICOM.RT compatibility
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K Number
K133655Device Name
RADIANCE V2
Manufacturer
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
Date Cleared
2014-01-31
(65 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
GMV SOLUCIONES GLOBALES INTERNET S.A.U.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
Device Description
Radiance V2 is a treatment planning system, that is, a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing alternative plans to find the best compromise, computing the clinical dose distribution. approving the plan and exporting it.
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