(145 days)
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.
ImagenSPECTTM is a Windows application which allows physicians and healthcare professionals to inspect. reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter setting, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
The ImagenSPECT™ system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation.
I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) premarket notification acceptance letter and a 510(k) summary for the ImagenSPECT™ device.
While it mentions that "Testing and comparison of technological characteristics and intended uses found that all components of the ImagenSPECT™ system are equivalent to the predicates," and that "half-count density (full-time scan, half dose/ half-time, full dose), reconstructed with ImagenSPECT using resolution recovery, iterative reconstruction was equivalent to the predicate with the same claim," it does not provide the specific details of the study, acceptance criteria, reported performance values, sample sizes, ground truth establishment, or expert qualifications that you asked for.
Therefore, I cannot compile the table or provide the requested information based on the given input.
§ 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.