Discovery MI Gen2
GE Medical Systems, LLC. • Radiology • 08/20/2021
Device Purpose
The Discovery MI Gen2 is an advanced hybrid PET/CT system designed for comprehensive diagnostic imaging, featuring a novel 30cm Axial Field of View configuration, Deep Learning Image Reconstruction, and automated acquisition tools to enhance scan efficiency and image quality. Its methodology combines sensitive SiPM-based PET detectors with LYSO/LGSO scintillator crystals and the Revolution EVO CT platform, enabling precise anatomical localization and quantitative assessment of radiopharmaceutical distribution for diverse oncological, neurological, and cardiological applications.
Summary
The Discovery MI Gen2 is a hybrid digital Positron Emission Tomography/Computed Tomography (PET/CT) diagnostic imaging system. Its primary purpose is to provide CT attenuation-corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals for assessing metabolic and physiological function across various body regions, including the whole body, head, heart, and specific organ systems. The system is also intended for stand-alone diagnostic CT imaging and supports a wide range of clinical applications in oncology, cardiology, and neurology, aiding in diagnosis, staging, treatment planning, therapy guidance, and monitoring of diseases. The key technological advancement in the Discovery MI Gen2 is the introduction of a 6-ring PET gantry configuration, providing an extended 30cm Axial Field of View (AFOV). This feature, along with scalable AFOV options (15cm, 20cm, 25cm), aims to enable shorter scan times by requiring fewer bed positions and to increase system sensitivity, which can contribute to reduced radiopharmaceutical doses and improved detection of small lesions. The PET detector units employ Silicon Photomultiplier (SiPM)-based light sensors with a choice of LYSO or LGSO scintillator crystals. The integrated CT system is the Revolution EVO, now enhanced with Deep Learning Image Reconstruction (DLIR). Additional features include an automated Whole Body Dynamic Acquisition (WBDA) capability for improved workflow in dynamic scanning and the AutoIN feature for streamlined patient table landmarking from the operator console. The system's imaging performance and the benefits of these modifications were substantiated through non-clinical engineering testing, phantom-based image quality evaluations, and physics analyses.
AI Regulatory Concerns
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Device Metadata
Relevant Clinical Questions
- Q1. How does the 30cm Axial Field of View configuration specifically impact scan time and patient throughput for common whole-body oncology protocols compared to the 25cm configuration?; What are the quantitative differences in image noise and lesion detectability when using LYSO versus LGSO scintillator crystals in the Discovery MI Gen2, particularly for low-count studies?; Can the Deep Learning Image Reconstruction (DLIR) in the CT component be optimized or demonstrate variable performance based on different positron-emitting radiopharmaceuticals used in the PET component for attenuation correction?; What specific user interface improvements and automation features in the Whole Body Dynamic Acquisition (WBDA) contribute to enhanced reproducibility and ease of use for complex dynamic PET studies?; How does the increased sensitivity of the 30cm AFOV system translate to practical improvements in image quality or dose reduction across the specified range of clinical applications, such as neurology or cardiology, beyond general oncology?
Risk Classification
ESL AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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Powered by SBOMator™Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
Analysis:
• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.
• Evidence of ML-BOM, SaaSBOM, HBOM, OBOM detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Not detected in AI-generated device summary: SBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.
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