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Discovery MI Gen2

GE Medical Systems, LLC. • Radiology • 08/20/2021

510(k)IEC 62304 Class B
FDA Summary PDF

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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Keywords

PET/CTDiscovery MI Gen230cm Axial Field of ViewDeep Learning Image Reconstruction (DLIR)SiPM detectorLYSO/LGSO crystalsWhole Body Dynamic Acquisition (WBDA)AutoINDiagnostic ImagingEmission Computed Tomography

Device Metadata

Submission Number
K211846
Company
GE Medical Systems, LLC.
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Generation
AI Subclass
image enhancement

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 Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

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Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score35/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan✓ Detected in Summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials(deep learning)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(platform)
✓ Detected
HBOMHardware Bill of Materials(sensor)
✓ Detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials(configuration)
✓ Detected

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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Discovery MI Gen2 - GE Medical Systems, LLC. | ESL FDA AI Device Intelligence