SCENARIA View Phase 5.0
FUJIFILM CorporationSCENARIA View Phase 5.0 is a multi-slice CT system that acquires axial volumes of the whole body in various scan modes. It includes AI-based features such as AutoPose that automatically recognizes and sets scan ranges for body parts, improving workflow and scan accuracy. The system supports high-quality imaging with motion correction and provides enhanced post-processing capabilities to assist clinicians in diagnosis and interventional guidance.
Intended Use
The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. It can be used for interventional needle guidance and for low dose CT lung cancer screening under approved protocols.
Technology
The system uses 128-slice CT technology with a rotating gantry, slip ring technology, and solid-state detector assembly collecting up to 64 slices simultaneously. The AI-based AutoPose function automatically sets scan and reconstruction ranges by recognizing body parts in localization scan images. Motion corrected reconstruction reduces image artifacts. RemoteRecon allows image reconstruction settings on an external PC.
Performance
Performance testing included bench tests confirming compliance with IEC standards and basic performance equivalence to predicate device. Clinical tests demonstrated that AutoPose reduces steps compared to manual positioning. Image quality with Body Still Shot motion correction was evaluated by MD review and found sufficient. No clinical testing required for AutoPositioning due to bench testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/10/2025
3 months - 2
FDA Approval
5/20/2025
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