Discovery MI Gen2
GE Medical Systems, LLC.The Discovery MI Gen2 is a PET/CT imaging system by GE Medical Systems designed to produce detailed attenuation-corrected PET images combined with CT scans. It helps clinicians by providing anatomically localized images of radiopharmaceutical distribution, aiding diagnosis, treatment planning, and monitoring of diseases such as cancer, neurological disorders, and cardiac conditions across various body regions.
Intended Use
The Discovery MI Gen2 PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging.
Technology
Discovery MI Gen2 is a hybrid digital PET/CT system combining a GE PET System and a CT System. It includes multiple detector ring size configurations up to 30 cm axial field of view, uses SiPM-based light sensors with LYSO or LGSO scintillator crystals, and incorporates CT software with Deep Learning Image Reconstruction (DLIR). It provides whole body dynamic acquisition with automation and an improved user interface.
Performance
The device underwent extensive engineering testing including performance evaluation with phantoms and image quality tests demonstrating diagnostic image quality and safety compliance with IEC 60601-1 Ed. 3, 21 CFR Subchapter J, and NEMA standards. Clinical testing was not required as the device design is based entirely on cleared predicate technology (Discovery MI).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/15/2021
2 months - 2
FDA Approval
8/20/2021
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