Search Results

For use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.

The C! SPECT Imaging System is an open gantry (with no external moving parts), upright seated device with an integrated patient chair, an acquisition station, two detectors, and hardware and software components. The patient chair is mechanized to accommodate patient loading and centering in the detector field of view.

The Apex XL-4 is intended for use as an acquisition of Nuclear Medicine SPECT and Planar Gamma Camera images.

The APEX XL-4 is a Gamma Camera - SPECT Imaging System. It is intended to acquire nuclear medicine gamma camera output data for previously-approved Elscint APEX Gamma Camera systems. This acquisition is performed in the same manner as the corresponding components of the equivalent device, K021823. The detector electronics, mechanical components, software, and the manufacturing specifications of the applicant system (the APEX XL-4) are substantially equivalent to the CardioSPECT SC, the legally marketed device.