(84 days)
The Northwestern Gated Blood Pool SPECT (NUMUGAS™) software program is indicated to use for the display of wall motion and quantification of left ventricular functional parameters from gated Tc-99m Blood Pool SPECT studies.
The Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) is used to display gated wall motion and for quantifying parameters of left-ventricular function from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
§ 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.