Synapse 3D Base Tools (V7.0)
FUJIFILM CorporationSynapse 3D Base Tools (V7.0) is advanced medical imaging software from FUJIFILM designed to assist trained professionals in reading, interpreting, reporting, and planning treatment using images from various modalities such as CT, MRI, X-ray, ultrasound, and nuclear medicine. It provides powerful 3D viewing tools, image fusion, segmentation powered by deep learning, and supports multiple modalities and anatomical regions, which enhances diagnostic workflows and treatment planning for adult patients.
Intended Use
Synapse 3D Base Tools is medical imaging software intended to provide trained medical professionals with tools to aid in reading, interpreting, reporting, and treatment planning for DICOM compliant images from various imaging devices including CT, MR, CR, US, NM, PT, and XA.
Technology
Software runs on Windows server/client computer systems, communicates via DICOM standard with various imaging devices and PACS, and provides tools like 2D/3D viewing, segmentation based on Fully Convolutional Network deep learning, volume rendering, image fusion, and multi-planar reconstructions.
Performance
Validation testing included software development life cycle process adherence, system and integration testing, and benchmark performance testing on 1086 US patient cases with deep learning organ extraction evaluated by DICE scores ranging from 0.6 to 0.99 depending on organ and modality. Cybersecurity and adherence to applicable standards are confirmed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/6/2024
5 months - 2
FDA Approval
5/21/2025
Other devices from FUJIFILM Corporation
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