Synapse 3D Base Tools (V7.0)

Synapse 3D Base Tools (V7.0) is medical imaging software that helps trained professionals read, interpret, and plan treatment using DICOM-compliant images from CT, MR, CR, US, NM, PT, and XA devices. It provides 2D/3D viewing, multi-planar reconstructions, segmentation, image fusion, measurements, reporting, and organ-specific analysis tools. The product is not intended for primary diagnostic interpretation of mammography images and is limited to adult patients over 22 years old.

Synapse 3D Base Tools V7.0 maintains the same classification (Class II, 21 CFR 892.2050), product codes (QIH, LLZ), and core functionalities as predicate V6.6, including DICOM interfaces, 2D/3D viewing, MPR, volume rendering, measurements, annotations, and reporting. New features include Pancreas Analysis, Rectal Analysis, Segmentation Viewer, Post-reconstruction Request, and Spatial Reproduction Display; all new segmentation functions use the same deep learning method (Fully Convolutional Network) as reference devices already cleared by FDA.

Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1–3.20) 2016; IEC 62304 Edition 1.1 2015-06 (Medical Device Software – Software Life Cycle Processes); ISO 14971:2019 (Medical Devices – Application of Risk Management); and Cybersecurity in Medical Devices guidance (April 8, 2022).

Synapse 3D Base Tools V7.0 is substantially equivalent to predicate V6.6 because both share identical intended use, classification, regulatory pathway, and core technical characteristics across 40+ device parameters. Performance testing on 1,086 U.S. patient cases demonstrated DICE accuracy scores averaging 0.60–0.99 across organ segmentation tasks, confirming functional parity. New segmentation features (Pancreas, Rectal, Viewer) reference already-cleared devices (Contour ProtégéAI K213976, SCENARIA View K190841) using established deep learning and visualization methods, raising no new safety or effectiveness questions.