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Deep Learning Image Reconstruction

GE Healthcare Japan Corporation • Radiology • 04/20/2023

510(k)IEC 62304 Class B
FDA Summary PDF

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

Deep LearningImage ReconstructionComputed Tomography (CT)Deep Neural Network (DNN)Noise ReductionImage QualityASiR-VTrueFidelityTM CT ImagesCT SystemsCross-sectional Imaging

Device Metadata

Submission Number
K230807
Company
GE Healthcare Japan Corporation
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 "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 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

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.

Cyber Score10/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan⚠ Not mentioned 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(training data, deep learning, neural network, algorithm, dataset)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(network, platform)
✓ Detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not 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 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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Deep Learning Image Reconstruction - GE Healthcare Japan Corporation | ESL FDA AI Device Intelligence