Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Class II · Cleared Apr 15, 2026
| K-number | K252258 |
| Device name | VERIQA RT EPID 3D |
| Applicant | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla |
| Product code | IYE |
| Device class | Class II |
| Decision date | Apr 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
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.
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.
Not stated in this summary.
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.
View the full FDA submission: accessdata.fda.gov