AnyScan 3.0 NM Scanner Family
Mediso Medical Imaging Systems, Ltd.The AnyScan 3.0 NM Scanner Family is a versatile imaging system designed for clinical use in nuclear medicine. It supports multiple imaging modalities including SPECT, PET, CT, and combinations thereof. It helps healthcare professionals detect, localize, diagnose, and evaluate lesions, tumors, and organ functions in various diseases including cancer, cardiovascular and neurological conditions. The system also aids in radiotherapy planning by providing detailed anatomical and physiological images, enhancing diagnostic accuracy and patient care.
Intended Use
The AnyScan 3.0 NM Scanner Family is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning or additional uses.
Technology
The device combines several imaging modalities: SPECT, PET, and CT. SPECT provides cross-sectional images by reconstructing radioisotope distribution, CT provides anatomical cross-sectional images from x-ray transmission data, and PET images represent tomographic scanning of radiopharmaceutical distribution. The system enables combined use for attenuation correction and anatomical-physiological image fusion. The Nucline software assists acquisition, display, analysis, and quantification of images. The system maintains independent functionality of individual modalities, supporting single and hybrid imaging.
Performance
Performance testing was conducted according to recognized standards including NEMA NU 1-2018 for SPECT and NEMA NU 2-2018 for PET. The device met all predetermined acceptance values for spatial resolution, energy resolution, count rate, sensitivity, and image quality comparable to predicate devices. CT performance was also comparable to predicate devices. The device passed electromagnetic compatibility, electrical safety, mechanical and thermal testing according to IEC standards.
Predicate Devices
No predicate devices specified
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