Device product
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Z-1181-2024
Product summary
- Firm
- PTW-FREIBURG
- Event
- Event 93988
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 US; 65 worldwide
- Official record key
device-enforcement:Z-1181-2024
Official wording
Reason: Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
Code information: UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1
Distribution pattern: GA
Derived failure modes
-
Unknown
Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.