Device Overview
The Cartesion Prime, PCD-IOOOA is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. This device is intended to gather metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions.
The CT component produces cross-sectional images of the body by computer reconstruction of X-ray transmission data, while the PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.
Indications for Use
This device is intended to be used by a trained healthcare professional to gather metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, therapeutic planning, and therapeutic outcome assessment of various medical conditions, including but not limited to cancer, cardiovascular disease, and brain dysfunction.
Technical Specifications
The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 780 mm and a maximum scanning field of 700 mm. The high-throughput PET system has a digital PET detector utilizing SiPM sensors with a temporal resolution of 280 ps. This device can acquire PET images of any desired region of the whole body and CT images of the same region for attenuation correction or image fusion.
Manual:
Download: 510(k) Premarket Notification – Cartesion Prime, PCD-IOOOA – Emission Computed Tomography System
Chat: Powered By VoiceSphere