K-numberK252258
Device nameVERIQA RT EPID 3D
ApplicantPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Product codeIYE
Device classClass II
Decision dateApr 15, 2026
DecisionSubstantially Equivalent
Regulation892.5050
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

VERIQA RT EPID 3D is a software tool for quality assurance in radiation therapy that reconstructs 3D dose distributions from EPID (electronic portal imaging device) images acquired before, during, or after treatment. It assists medical physicists in detecting errors related to treatment planning, plan delivery, patient anatomy changes, and patient positioning deviations, but cannot be used alone to modify treatment plans or for treatment planning itself.

Technological characteristics

VERIQA RT EPID 3D uses a clinically validated direct back-projection algorithm for 3D dose reconstruction, whereas the predicate device PerFRACTION uses a forward-calculation method. The subject device provides additional analytical features including 3D patient dose reconstruction, 3D gamma distribution visualization, and dose-volume histogram metrics, though both devices support pre-treatment and in vivo EPID dosimetry, automated evaluation processing, and template-based assessments.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Both devices share identical intended use for EPID-based patient-specific quality assurance, and published evidence demonstrates comparable error-detection capabilities for clinically relevant delivery deviations despite algorithmic differences. The back-projection method's additional analytical features represent enhancements in analytical depth rather than changes in intended use or clinical operation, introducing no new safety or effectiveness concerns beyond those already present in EPID-based QA approaches.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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