Mobius3D (4.1)
Varian Medical SystemsMobius3D (4.1) is a software tool designed for radiation therapy clinics to perform quality assurance, treatment plan verification, and patient alignment analysis. It calculates three-dimensional radiation dose distributions based on treatment plans and imaging data, helping clinicians verify and ensure accurate radiation therapy without directly interacting with the delivery system or patients.
Intended Use
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom based on read-in treatment plans and images such as computed tomography and cone beam computed tomography.
Technology
Mobius3D operates as a software-only quality assurance and treatment plan verification tool. It analyzes read-in treatment plans and imaging data (CT and cone beam CT) to calculate radiation dose and assess patient alignment. Changes in version 4.1 include software updates, improved MLC modeling, hardware and OS upgrades, and security enhancements. The software uses multi-level testing, including unit, integration, and end-to-end tests, to ensure accuracy and reliability.
Performance
Software verification and validation testing was conducted following FDA guidance, including unit, integration, and end-to-end testing. Dose calculation accuracy and MLC modeling were assessed by comparing the new version to previous releases, measurements, and Treatment Planning System data. Cybersecurity and interoperability were also evaluated. No clinical or animal studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/14/2025
4 months - 2
FDA Approval
5/16/2025
Other devices from Varian Medical Systems
- CT/ MR Tandem and Ovoid Set2025 • 510K
- Intracavitary/Interstitial System2025 • 510K
- Identify (4.0)2025 • 510K
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