Intended Use

Diagnostic imaging system combining PET and multi-slice CT that provides metabolic and functional information to assist in evaluation, detection, diagnosis, staging, and therapeutic planning of oncological, cardiovascular, and neurological diseases. Can be operated as a whole body multi-slice CT scanner.

Technology

Combines high-end multi-slice helical CT scanner and digital PET detector with SiPM sensors; uses AiCE-i deep learning artificial neural network to improve PET image quality and reduce noise; capable of PET/CT image fusion; operates independently as CT scanner.

Performance

Bench testing demonstrated improved image quality, quantification accuracy and noise reduction using AiCE-i for PET compared to conventional reconstruction methods; phantom and clinical studies showed no artifacts, preserved quantification, higher signal-to-noise ratio, and diagnostic image quality confirmed by experienced nuclear medicine physicians.

Predicate Devices

No predicate devices specified

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