Synapse PACS (7.5)
FUJIFILM Healthcare Americas CorporationSynapse PACS (7.5) by FUJIFILM Healthcare Americas Corporation is a web-based software application designed to manage, display, and process medical images from various modalities. It provides advanced tools such as measurements, regional segmentation, 3D volume rendering, fusion, and structured report generation to support clinicians like radiologists and cardiologists in reading, interpreting, and planning patient care efficiently.
Intended Use
FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC networked with a Synapse PACS server. It processes medical images from DICOM and non-DICOM sources and provides toolsets for measurements, regional segmentation, clinical calculations, and structured report creation to aid in image interpretation and treatment planning.
Technology
Synapse PACS software integrates volume rendering and 3D volume viewing for CT and MR images using algorithms previously cleared in Synapse 3D (K221677). It includes semi-automatic segmentation using a 2-point VOI tool and an AI-based bone removal tool to enhance vessel visibility. These tools run on off-the-shelf PCs with a web-based interface and support a range of DICOM and non-DICOM medical images.
Performance
Performance testing included evaluation of the bone removal algorithm using Dice Similarity Coefficient (mean 0.959) and 95% Hausdorff Distance (mean 1.367 mm) exceeding predefined acceptance criteria. Testing used images from 72 patients across multiple body regions, vendors, and imaging protocols. Ground truth was established by dual-board certified radiologist consensus.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/26/2024
7 months - 2
FDA Approval
6/30/2025
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