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510(k) Data Aggregation
K Number
K150767Device Name
EDOSE
Manufacturer
Date Cleared
2015-08-17
(146 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are planned to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
Device Description
EDOSE is a three-dimensional dose verification system making IMRT verification becomes accurate, efficient and fast. This system fully supports Varian and Elekta accelerators; it can verify conventional IMRT, IMRT and VMAT. With Collapsed Cone convolution algorithm, it realizes the reconstruction of the three-dimensional dose and combined with the CT image, making the three-dimensional distribution of the dose at a glance. By using CUDA parallel algorithms, EDOSE quickly and efficiently provide the entire program as well as the calculation results of individual GAMMA radiation field, and visually display GAMMA distribution. Meanwhile, EDOSE provides automatic correction of absolute dose and EPID position to support DVH comparison chart and the move of isodose curve. Through a series of powerful functions, the accelerator quality assurance has become so easy.
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