Synapse 3D, Synapse 3D Base Tools v6.1
Fujifilm CorporationSynapse 3D Base Tools v6.1 by Fujifilm is an advanced medical imaging software designed to assist trained medical professionals in viewing, analyzing, and interpreting medical images from a variety of modalities such as CT, MRI, PET, and ultrasound. It provides multi-planar reconstructions, 3D volume rendering, image fusion, segmentation using deep learning algorithms, and other sophisticated tools to support diagnosis and treatment planning, enhancing the workflow and accuracy for radiologists and clinicians.
Intended Use
Synapse 3D Base Tools is medical imaging software intended to aid trained medical professionals in reading, interpreting, reporting, and treatment planning from DICOM compliant images acquired from various imaging devices excluding primary diagnostic interpretation of mammography.
Technology
Synapse 3D Base Tools is a Windows server/client software that connects via DICOM standard to medical devices and PACS systems to retrieve and manage image data, providing basic and advanced imaging tools such as 2D/3D viewing, multi-planar reconstructions, segmentation using deep learning algorithms, image fusion, virtual endoscopy, and diffusion-weighted MRI analysis.
Performance
Performance testing included extensive software development processes, verification and validation testing including functionality, integration, usability, and benchmark testing using clinical images to demonstrate accurate segmentation, detection, and registration. All tests passed per design specifications. The product maintains cybersecurity protections following FDA guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/14/2020
3 months - 2
FDA Approval
2/9/2021
Other devices from Fujifilm Corporation
- EW10-EC02 Endoscopy Support Program2023 • 510K
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