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510(k) Data Aggregation
K Number
K112060Device Name
RADIANCE
Manufacturer
GMV AEROSPACE AND DEFENCE S.A.
Date Cleared
2012-01-06
(171 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
GMV AEROSPACE AND DEFENCE S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
radiance is a software system intended for treatment planning and analysis of intraoperative radiation therapy by means of electron beams.
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 shall be clinically qualified radiation therapy staff trained in using the system.
Device Description
radiance 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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