FDA-Device2024-02-28Class II
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.
PTW-FREIBURG
Hazard
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.
Sold states
GA
Affected count
1 US; 65 worldwide
Manufactured in
Lorracher Str. 7, N/A, Freiburg Im Breisgau, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1181-2024Don't want to check this manually?
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