Deep Learning Image Reconstruction
GE Healthcare Japan Corporation • Radiology • 04/20/2023
Device Purpose
GE Healthcare's Deep Learning Image Reconstruction (DLIR) software utilizes a trained Deep Neural Network to enhance computed tomography image quality by reducing noise and artifacts, aiming for an FBP-like appearance while maintaining the performance of iterative reconstruction techniques like ASiR-V. This technology is being extended to additional GE CT scanner platforms to offer improved diagnostic confidence across various clinical applications, including head, body, cardiac, and vascular imaging for all ages.
Summary
GE Healthcare's Deep Learning Image Reconstruction (DLIR) is an advanced software designed for computed tomography (CT) systems, employing a dedicated Deep Neural Network (DNN) to reconstruct cross-sectional images. The core science involves the DNN being trained to model and mitigate noise propagation within the CT system, thereby enhancing image clarity and producing images marketed as "TrueFidelityTM CT Images." This technology is intended for comprehensive CT applications, including head, whole body, cardiac, and vascular imaging, across all patient age groups and supporting various scan modes such as Axial, Helical, and Cardiac acquisitions. DLIR offers user-selectable strengths (Low, Medium, High) to optimize image output for specific clinical requirements. DLIR aims to provide an image appearance comparable to traditional Filtered Back Projection (FBP) techniques while retaining the superior performance characteristics of GE's ASiR-V iterative reconstruction, specifically in areas like low image noise, excellent low-contrast detectability, high-contrast spatial resolution, and effective streak artifact suppression. This specific iteration of DLIR involves porting an established algorithm to additional GE CT platforms (Revolution EVO, Revolution Maxima, Revolution Ascend, and Discovery CT750 HD family), with the fundamental technology remaining consistent. The system's capabilities were evaluated through extensive non-clinical engineering bench tests, comparing DLIR images against those reconstructed with ASiR-V using identical raw datasets across a range of metrics including noise profiles, spatial and contrast resolution, artifact analysis, and performance in specialized scenarios like pediatric imaging and low-dose lung cancer screening protocols.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. How does the "TrueFidelityTM" image appearance achieved by DLIR quantitatively compare to traditional FBP images, particularly in terms of texture and radiologist preference for specific diagnostic tasks?; What are the computational overhead and reconstruction time differences when using the Low, Medium, and High strengths of DLIR, and how do these impact clinical workflow on the newly supported CT platforms?; Beyond the listed performance metrics (noise, LCD, MTF), are there any specific types of artifacts or image characteristics where DLIR might perform differently (better or worse) than ASiR-V or FBP, especially in challenging patient populations or complex anatomical regions?; How does the training dataset for the Deep Neural Network account for variability across different patient demographics, pathologies, and the specific characteristics of the newly targeted CT scanner models (Revolution EVO, Maxima, Ascend, Discovery CT750 HD family)?; What is the specific impact of DLIR on quantitative imaging tasks, such as CT number accuracy and uniformity for densitometry or radiomics, compared to ASiR-V and FBP, especially at varying dose levels?
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 detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.
• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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