(104 days)
Siemens/CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.
Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged. Attenuation correction is utilized to enable quantitative interpretation of the acquired emission data.
Software version 7.1 and Single Photon Detection Transmission Scan System for ECAT PET Scanners. ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner. Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged.
The provided text, primarily a 510(k) clearance letter and an "Indications For Use" statement, does not contain the specific details about acceptance criteria, device performance results, or a detailed description of a clinical study as requested.
The document indicates that the device (ECAT Pet Scanner System and Software Version 7.1) was found substantially equivalent to a predicate device, allowing it to be marketed. However, it does not provide the technical performance data that would typically be included in a study report.
Therefore, I cannot fulfill the request to build the table and answer the specific questions about the study based on the provided text.
To provide the requested information, a document containing the technical specifications, performance claims, and the study report (or summary of the study results) would be necessary.
§ 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.