(14 days)
The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, intages are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, Tl-201, Co-57.
The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness or standalone studies. The document is an FDA 510(k) clearance letter for the Cardiocam Model 9CSY0799, confirming its substantial equivalence to a predicate device and specifying its indications for use. It does not include the technical study details that would be required to answer your request.
§ 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.