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The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. Same as predicate.

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The “ISOCAM II” manufactured by Park Medical Systems Inc. is a Single Photon Emission Computed Tomography (SPECT) gamma camera which is intended to image the distribution of radionuclides in the body by means of a single photon radiation detector. This system includes signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. Same as ISOCAM II.

The ISOCAM II (Dual Head Gamma Camera) is a Single Photon Emission Computed Tomography (SPECT) gamma camera. This 510(K) is being submitted because of a modification to our ISOCAM II, more specifically, an additional collimator for the ISOCAM II, that allows better images. This modification changes the effectiveness of the ISOCAM II, therefore, we are submitting another premarket notification. The collimator is called MCAT™, which stands for Modular Coded Apperture Technology.