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510(k) Data Aggregation
K Number
K132944Device Name
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
Manufacturer
GE HUNGARY KFT
Date Cleared
2014-03-14
(176 days)
Product Code
KPQ
Regulation Number
892.5840Why did this record match?
Applicant Name (Manufacturer) :
GE HUNGARY KFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
Device Description
AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist nuclear medicine physicians and trained healthcare professional) to assist treatment planning.
AdvantageSim MD with MR pelvic organ at risk segmentation Option is used to provide MR based prostate and pelvic organs-at-risk segmentation. A suite of semi-automated MR based organ segmentation contouring allows generating complex structures around organs at risk. These contours overlay on the co-registered CT planning image.
The segmentation methods in the modified device are semi-automatic. The user has to place seed points to identify an inner point of the organ to contour.
The software offers a suite of manual contour editing tools enabling the user to edit, modify, or change contours generated from the MR segmentation tools to their desired configuration based on their medical and clinical knowledge and experience. The results provided by the software needs to be approved by the experienced clinician and can always be modified or corrected by him/her. It is up to the expert user to accept the result without any change, reject it completely and delineate manually, or modify the result and then save it. The software does not provide any auto-detection or auto-saving functionalities.
Same as the predicate devices, the clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images, regardless of the accuracy of the output generated by the software.
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K Number
K132045Device Name
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
Manufacturer
GE HUNGARY KFT
Date Cleared
2013-09-04
(64 days)
Product Code
KPQ
Regulation Number
892.5840Why did this record match?
Applicant Name (Manufacturer) :
GE HUNGARY KFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
Device Description
AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist, nuclear medicine physicians and trained healthcare professional) to assist treatment planning.
Ask a Question
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