TruSPECT Processing Station
Spectrum Dynamics Medical, Ltd.The TruSPECT Processing Station is a software-only medical device designed to support visualization, quantitation, and analysis of SPECT and related nuclear medicine images for clinical diagnostic purposes. It can process multimodal imaging datasets, including fused CT and MR images, and incorporates an AI-based noise reduction module called TruClear AI to enhance image quality. This helps clinicians in cardiac and other functional imaging evaluation by improving image clarity and supporting diagnosis and treatment planning.
Intended Use
TruSPECT is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body, supporting visualization, quantitation, and analysis of SPECT and fused CT/MR images for clinical diagnosis, primarily cardiac applications.
Technology
Software-only medical device operating on Windows OS; supports visualization and analysis of nuclear medicine and CT images; includes AI-based TruClear AI noise reduction module which uses pre-trained neural networks and traditional image processing algorithms integrated into reconstruction and post-processing workflow; maintains same fundamental technology as predicate device.
Performance
Verification and validation testing using phantom and clinical data demonstrated that the addition of TruClear AI module meets performance specifications and maintains safety and effectiveness; clinical validation used multi-center retrospective datasets, showing substantial concordance of denoised images with high-count standard images; quantitative and reader analyses confirm image quality improvement without diagnostic compromise.
Predicate Devices
No predicate devices specified
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