Mobius3D (4.1)

Mobius3D 4.1 is quality assurance software used by trained radiation oncology personnel to verify treatment plans and analyze patient alignment in radiation therapy. It calculates radiation dose three-dimensionally based on treatment plans from treatment planning systems and can incorporate external radiation field measurements and daily treatment images, but does not itself design plans or control delivery devices.

Both the subject device (version 4.1) and predicate (version 4.0) are computer-based software for treatment planning quality assurance. Key changes in 4.1 include: RapidArc Dynamic Support, improved Varian MLC modelling (tongue and groove), Ubuntu OS upgrade, CouchDB upgrade, new Dell hardware platform support, recurring automated data wipe for performance, cybersecurity and interoperability enhancements, and removal of Dose Lab Viewer Module and SmartConnect features.

ISO 14971:2019 (risk management), ISO 15223-1:2021 and ISO 20417:2021 (labeling/symbols), IEC 62304:2006+A1:2015 (software lifecycle), IEC 62366-1:2015+A1:2020 (usability), IEC 61217:2011 (radiotherapy equipment), UL ANSI 2900-1:2017 and 2900-2-1:2017 (cybersecurity), and IEC 81001-5-1:2021 (health IT security).

The subject device operates on the same fundamental principle as the predicate—it is software-only quality assurance tool that reads treatment plans and performs independent dose verification. Verification and validation testing demonstrates the new features (RapidArc support, improved MLC modelling) maintain or enhance accuracy compared to the predicate and treatment planning systems. The changes constitute enhancements rather than fundamental alterations to the device's safety profile or intended use.