TruSPECT Radiological Image Processing Station
Spectrum Dynamics Medical LtdThe TruSPECT Radiological Image Processing Station is a nuclear medicine imaging software system designed to process and display SPECT images alongside CT/MR scans for enhanced clinical diagnosis, including attenuation correction and quantitative assessment. It supports AI-based attenuation correction to improve image quality and aids clinicians, particularly for cardiac imaging and other clinical applications, by providing advanced visualization, segmentation, and quantitative tools.
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. The device uses various processing modes supported by clinical applications to enhance image quality, depicting, localizing, and quantifying radionuclide tracers and anatomical structures in scanned body tissue for diagnostic purposes.
Technology
TruSPECT includes manual and automatic segmentation, quantitative analysis tools, emission-based attenuation correction using a deep learning model (TruCorr) to estimate attenuation corrected SPECT images directly from non-attenuation corrected ones without anatomical images, and supports CT-based correction. It is Windows OS based, can be configured with multiple software options, and integrates pre-trained neural networks in the iteration reconstruction process.
Performance
The device underwent thorough preclinical validation including risk analysis, design reviews, software development lifecycle adherence, unit and integration testing, performance and safety tests, simulated use testing, and clinical evaluation of the AI-based algorithm using representative clinical exams reviewed by nuclear medicine experts. No new safety concerns were identified and performance was demonstrated as substantially equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/16/2021
1 month - 2
FDA Approval
8/16/2021
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