Cartesion Prime (PCD-1000A/3) V10.8
Canon Medical Systems CorporationCartesion Prime (PCD-1000A/3) V10.8 is a diagnostic imaging system that combines Positron Emission Tomography (PET) and multi-slice Computed Tomography (CT). It provides fused images to help clinicians assess metabolic and functional information for evaluating oncological, cardiovascular, and neurological diseases. The device incorporates an AI algorithm called AiCE-i that improves PET image quality and reduces noise using deep learning methods, facilitating better diagnosis and treatment planning.
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
Device Timeline
- 1
Submission
11/10/2020
5 months - 2
FDA Approval
4/23/2021
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