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510(k) Data Aggregation
K Number
K172534Device Name
LINACwatch, LinacView
Manufacturer
Date Cleared
2017-10-27
(66 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
QualiFormeD Sarl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.
QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.
Device Description
QualiFormeD LINACWATCH / LINACVIEW is a standalone software product analyzes logfiles generated by Varian and Elekta linear accelerators during radiation treatments. Logfile analysis can be with respect to the "prescription" DICOM radiotherapy (RT) Plan or with respect to the first logfile in a series of logfiles for each treatment and each beam. Initial logfiles that may be created for pre-treatment intensity-modulated radiation therapy (IMRT) quality assurance (QA) can be excluded from treatment session analysis.
The preferred method of running QualiFormeD LINACWATCH / LINACVIEW is in "batch" mode. In this mode, QualiFormeD LINACWATCH / LINACVIEW automatically processes logfiles and analyzes them, sending emails to designated staff for non-compliant results over an internet connection.
QualiFormeD LINACWATCH / LINACVIEW allows the user to verify for every treatment, in real time, with email notifications on alert or failure, the following parameters:
- The position of each moving multi-leaf collimator (MLC) leaf; ●
- The position of MLC carriages and jaws;
- The percentage of monitor units (MUs) delivered; ●
- The gantry rotation angle; ●
- The collimator rotation angle;
- The beam on/off statistics; and
- . The reconstructed integrated fluence.
Additionally, after any number of treatments has been analyzed, QualiFormeD LINACWATCH / LINACVIEW allows the user to create RT Plans that can simulate the composite behavior of the analyzed logfiles. These RT Plans can be imported into the treatment planning system (TPS) to compare intended doses with those actually delivered, although this estimated dose does not include dosimetric changes due to patient setup or geometric changes. Adobe Acrobat® PDF reports documenting machine performance can be created at any point during treatment.
At the end of a course of treatment when the treatment series is closed, a composite RT Plan is automatically created that summarizes the composite behavior of all analyzed logfiles as well as two (2) final reports, a short and a comprehensive report, that documents all aspects of the treatment course.
Step and Shoot, Sliding Window, and Volumetric Modulated Arc Therapy (VMAT) IMRT techniques are supported.
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