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The intended use of the CardioSPECT SC and the CardioSPECT D90 is to detect the location and distribution of gamma ray emitting radionuclides in the human body and store the data for analysis as the same equivalent device, K013353. Intended use is to detect & image the distribution of radionuclides in the body, when the radiopharmaceutical is administered in the body.

The SC and D90 are scintillation detector, Nal, systems with PMT a) light gathering capacity. The D90 has two (2) detectors and the SC has one detector both with the ability to rotate these detectors around the patient. The system uses a collimator on each detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The SC and D90 are capable of both Planar (Class I) and SPECT or ECT (Class ii) operation. The acquisition/processing computer is a presently approved system sold and supported by NC Systems, Inc. but manufactured by Segami Corporation. This application is for the ECT device-qamma camerasystem(s) and not the previously approved computer.

NeuroSpect QUAD is intended to detect and obtain planar and SPECT images of the distribution of a gamma emitting radionuclide administered in the body.

Gamma Camera NeuroSpect QUAD Gamma Camera Emission Computed Tomography System. The NeuroSpect QUAD nuclear imaging system had four (4) rectangular field of view detector heads.