(80 days)
The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer, it is used in planar and whole-body and SPECT imaging.
The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer. The acquisition hardware is a microprocessor-based system and is separate from the host personal computer. It uses simple, window-based GUIs.
The provided text describes the "NumaStation" device and its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria, device performance, results of a study, or details about ground truth establishment or sample sizes.
The document is a 510(k) submission summary for the NumaStation, a nuclear medicine data acquisition system. It focuses on demonstrating substantial equivalence to a predicate device (Gamma 600t) based on functional similarities and adherence to EMC and NEMA standards.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The text primarily addresses regulatory compliance through substantial equivalence, not performance metrics derived from a detailed study.
§ 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.