Synapse PACS (7.5)

Synapse PACS (7.5) is a web-based medical image management and processing software that runs on standard PC hardware. It processes DICOM and non-DICOM medical images and provides tools for measurements, segmentation, clinical calculations, and structured report creation to aid radiologists and clinicians in reading, interpreting, and treatment planning.

The subject device adds volume rendering techniques, 3D tools, 2-point volume of interest (VOI) segmentation, and bone removal functionality compared to the primary predicate. These features enable 3D visualization for CT and MR images; the bone removal tool uses an improved AI algorithm to enhance vessel visibility by masking bone regions.

Not stated in this summary. The document references performance metrics (Dice Similarity Coefficient and 95% Hausdorff Distance) but does not cite specific ISO, IEC, ASTM, or other consensus standards.

The new features—volume rendering, 3D tools, 2-point VOI, and bone removal—were sourced from Synapse 3D (K221677), which is already cleared and marketed. Volume rendering algorithms were integrated unchanged; the 2-point VOI algorithm (called Tumor Boundary Segmentation in Synapse 3D) was integrated unchanged; and the improved bone removal algorithm demonstrated non-inferior performance (DSC 0.959, 95% HD 1.367 mm) meeting predefined acceptance thresholds across diverse image subgroups. Since the reference device already possesses these same features and the integrated algorithms performed equivalently, the additions do not affect safety or efficacy.