Cartesion Prime (PCD-1000A/3) V10.15
Canon Medical Systems CorporationThe Cartesion Prime (PCD-1000A/3) V10.15 is a PET/CT emission computed tomography system designed for diagnostic imaging. It helps clinicians by producing high-quality fused metabolic and anatomical images through PET and CT scans, improved by AI-driven noise reduction and motion correction. This aids in the evaluation, diagnosis, and treatment planning of various diseases such as cancer, cardiovascular and neurological disorders.
Intended Use
The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems producing fused images for metabolic and physiologic function assessment to assist clinical evaluation and management of various diseases.
Technology
PET/CT system with multi-slice CT and PET components; uses AiCE deep learning AI neural network for denoising and image quality improvement of PET images; includes a deviceless respiratory gating system that automatically generates gating signals for motion corrected PET imaging to improve lesion detection and image accuracy affected by respiratory motion.
Performance
The device underwent extensive performance testing including bench testing, software validation, and clinical evaluation involving 610 scans demonstrating improved image quality and noise reduction with AiCE, and effective motion correction using the deviceless respiratory gating, supporting safety and effectiveness for diagnostic use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/15/2023
2 months - 2
FDA Approval
9/12/2023
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