Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
RAYSOLUTION Healthcare Co., LtdThe DigitMI 930 is a PET/CT imaging system that combines positron emission tomography and computed tomography to produce detailed images of metabolic and physiological functions in the body. It helps clinicians detect, localize, evaluate, diagnose, and monitor a wide range of conditions including cancer, cardiovascular disease, and neurological disorders by providing precise anatomical and functional imaging.
Intended Use
The PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It images the whole body and multiple organs and is also intended for standalone diagnostic CT imaging.
Technology
The DigitMI 930 is a PET/CT diagnostic imaging system that combines a Positron Emission Tomography system and a Computed Tomography system. It consists of a scanning system, power distribution unit, table system, data processing system, and console system. The PET system includes a 72-ring LYSO detector and the CT has 64 physical rows of detectors.
Performance
Non-clinical tests were conducted to verify that the device met design specifications and was substantially equivalent to the predicate device. The device underwent performance testing and software validation, adhering to various IEC, ISO, and NEMA standards. No clinical study was included in the submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/6/2024
8 months - 2
FDA Approval
1/27/2025
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