syngo.via RT Image Suite VC10

syngo.via RT Image Suite VC10 is image analysis and radiation therapy preparation software that provides multimodality image viewing, registration, segmentation, synthetic CT generation, and patient-marking workflows. It helps prepare treatments for brachytherapy, particle therapy, and external beam radiation therapy by enabling clinicians to view existing contours, create/edit/modify contours of anatomical structures, and export data to treatment planning systems.

VC10 adds MR-based autocontouring for brain metastases and organs-at-risk, expands CT autocontouring to 29 new organs with improved segmentation guidelines, upgrades synthetic CT from a 2D to a 3D deep-learning algorithm for improved Hounsfield Unit accuracy, and enables bidirectional isocenter coordinate transfer with RTP laser positioning systems (previously send-only). The underlying deep-learning architecture remains unchanged; these represent functional enhancements.

ISO 14971:2019 (risk management), IEC 62304:2006+A1:2016 (software lifecycle), IEC 62366-1:2015+A1:2020 (usability engineering), IEC 62083:2009 (radiotherapy treatment planning systems), IEC 81001-5-1:2021 (health software security), IEC 61217:2011 (radiotherapy equipment coordinates), UL ANSI 2900-1:2017 and 2900-2-1:2017 (cybersecurity), and ISO 13485 (quality management).

The subject device maintains the same fundamental technology and operational principles as predicate syngo.via RT Image Suite VB80 (K232799). Software verification and validation testing demonstrates equivalent or superior safety and effectiveness across 760 patient subjects and multiple independent test datasets. All autocontouring models met predefined acceptance criteria based on DICE coefficients, ASSD, sensitivity, and clinical user evaluation. VBrain (K203235) serves as a reference device for metastasis contouring, with syngo.via VC10 demonstrating comparable performance metrics (92.5% sensitivity vs. 90.3%).