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510(k) Data Aggregation
K Number
K162629Device Name
IQM Integral Quality Monitor (also IQM)
Manufacturer
Date Cleared
2016-10-20
(29 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
IRT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy.
The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data over time as part of a quality assurance program.
Device Description
The IQM System is designed for the verification of radiation therapy treatments delivered with a linear accelerator. The IQM consists of an electronic detector device and software used to control the device and to process and display the results. Comparisons may be made with expected / previously measured data, results reviewed and documented for quality assurance purposes, and deviations from the expected signal can be detected and reported. Where results can be presented on a segment by segment basis, the realtime reporting of results gives the user the opportunity to detect serious deviations still during treatment, potentially aiding radiation therapy professionals in increasing patient safety.
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