(13 days)
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.
The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.
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The provided text is a 510(k) summary for the GE Quasar System, a nuclear medicine imaging system. It details the device's name, submitter, classification, and intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes, or expert qualifications.
Therefore, I cannot provide the requested information based on the given document.
The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices for the purpose of FDA clearance. It does not include the detailed performance study results that would typically contain acceptance criteria and performance metrics.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.