GMV SOLUCIONES GLOBALES INTERNET SA

Address:Isaac Newton 11,Tres Cantos Madrid (Province),ES

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System,Planning,Radiation Therapy Treatment (MUJ) (2)

Premarket Exempt

Clear

radiance - 08436567540000 Catalog Number :

Device Description : Radiance V3 is a software system intended for treatment planning and analysis of Radiance V3 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 V3 shall be clinically qualified radiation therapy staff trained in using the system.

Device Class : 2

Duns Number: 462279436

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

radiance - 08436567540017 Catalog Number :

Device Description : Radiance V4 is a software system intended for treatment planning and analysis of Radiance V4 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 V4 shall be clinically qualified radiation therapy staff trained in using the system.