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The Extremity CT Imaging System is intended for x-ray computed tomography imaging of upper extremities of adult patients.

The device is intended to be operated in a professional healthcare environment by qualified and trained healthcare professionals only.

The Extremity CT Imaging System™ is a computed tomography x-ray system designed for imaging of the upper limb. The device acquires volumetric spectral CT imaging using helical rotation of a single x-ray source and photon counting detectors with the limb stationary throughout the scan.

The use of photon-counting technology in the Medipix X-ray detector enables the scanner to detect individual X-ray photons with greater precision in comparison to conventional CT scanners, which typically rely on energy-integrating detectors. By counting the number of photons that pass through the body part and measuring their energy levels, the scanner can capture more detailed information about the composition of the tissues being imaged.

The Extremity CT Imaging System is intended for use in professional healthcare facility environments, excluding oxygen-rich environments, by trained medical professionals The imaging data produced by the system is intended to support diagnosis, treatment planning, and monitoring of patient conditions. It is to be noted however that actual diagnosis is not performed using any part of this software. The images produced by the system serve as a valuable tool for assessing pathologies related to the hand and wrist of adult patients

The device is meant for prescription use only by qualified and trained medical professionals.

The scanner is compact, with a small footprint and an entry port of diameter 12 cm (4.8 inches) ideally suited for imaging the hand and wrist. The scanner is mobile but must be used in a stationary position.

The system is designed to provide a streamlined workflow from patient scanning to the delivery of high-quality images, to ultimately support patients' diagnosis. Once the data has been processed within the scanner's computer, it is accessed from the Workstation using the specialized image processing software, MARS Vision, for post-processing. This stage involves advanced image manipulation, including multiplanar reformats (MPR) and 3D visualization (direct volume rendering and maximum intensity projection). Following the data review and post-processing in MARS Vision, high-quality images in DICOM format are created and uploaded to the facility's Picture Archiving and Communication System (PACS) system, where they are securely stored and made available for review.

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