syngo.via MI Workflows; Scenium; syngo MBF

syngo.via MI Workflows is medical image management and processing software that enables viewing, manipulation, quantification, analysis, and comparison of molecular imaging data (PET, SPECT) combined with anatomical imaging (CT, MR). It is intended for use by trained healthcare professionals to aid in disease management across oncology, cardiology, neurology, and organ function assessment, and can support radiotherapy treatment planning.

The device maintains the same core technological elements as the predicate: software-only architecture, server/client design, support for PET/SPECT/CT/MR data, workflow activities (preprocessing, evaluation, reporting, storage), feature licensing, and SUV value calculations. New features include improved lung segmentation with lobe-specific algorithms, Deauville Score integration, CT oncology tools (RECIST/WHO assistance, lung CAD), liver reference region placement enhancements, and expanded organ processing for cardiac and hepatic applications.

Not stated in this summary.

Substantial equivalence is established because: (1) indications for use are identical to the predicate; (2) intended use and fundamental scientific technology remain unchanged; (3) new features do not raise different safety or effectiveness questions; (4) no predicate features were removed; and (5) performance validation demonstrates the lung segmentation algorithm achieves higher Dice coefficients than the predicate on an independent 20-patient cohort, while the PERCIST liver reference region placement algorithm shows fewer intersections with suspicious uptake regions (4 cases vs. 13 in predicate) using the same validation methodology as the predicate devices.