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Sonic DL

GE Medical Systems,LLC (GE Healthcare) • Radiology • 05/30/2023

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

Sonic DL is an advanced software feature utilizing a deep learning algorithm to reconstruct high-quality cardiac MR images from significantly under-sampled data. This methodology enables highly accelerated acquisition protocols, including single-heartbeat and free-breathing cine imaging, thereby reducing scan times while maintaining diagnostic accuracy for functional cardiac assessments on GE 1.5T and 3.0T systems.

Summary

Sonic DL is a software feature developed by GE Healthcare for their 1.5T and 3.0T MR systems, designed to significantly accelerate cardiac cine examinations. Its core technology involves a deep learning-based reconstruction algorithm that processes highly under-sampled magnetic resonance data, enabling much faster image acquisition compared to conventional methods like ASSET acceleration. The software is an optional, key-activated component integrated into the MR system, intended for cardiac imaging across all patient age groups, including those requiring free-breathing scans, with the goal of reducing scan times while maintaining image quality. The performance of Sonic DL was validated through extensive nonclinical and clinical testing. Nonclinical studies using simulated phantom data demonstrated its ability to reconstruct high-quality images with good temporal sharpness from under-sampled data, comparable to fully sampled images. Clinical studies, involving over 100 image series from patients (including those with various cardiac pathologies) and healthy volunteers, confirmed these findings. Reader studies showed that Sonic DL images maintained diagnostic quality and yielded functional cardiac measurements (e.g., left ventricular volumes, ejection fraction, cardiac output) with variability smaller than or comparable to conventional techniques, while significantly reducing scan times. Notably, Sonic DL enables acceleration factors as high as 12, facilitating single-heartbeat imaging even during free breathing, with results showing close agreement to traditional breath-hold methods and, in some cases, improved image quality over conventional free-breathing techniques.

AI Regulatory Concerns

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Keywords

Sonic DLDeep LearningImage ReconstructionCardiac MRIAccelerated AcquisitionUnder-sampled DataCine ImagingMagnetic ResonanceFunctional Cardiac MeasurementsScan Time Reduction

Device Metadata

Submission Number
K223523
Company
GE Medical Systems,LLC (GE Healthcare)
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 deep learning model in Sonic DL generalize across diverse patient populations with varying cardiac pathologies not extensively covered in the 57-subject clinical trial?; What are the specific computational requirements (e.g., processing time, hardware) for the Sonic DL reconstruction algorithm, and how do these impact workflow efficiency in a clinical setting compared to conventional reconstruction?; Beyond the evaluated metrics (PSNR, RMSE, SSIM, MAE, functional measurements), are there any subtle image artifacts or alterations introduced by the deep learning reconstruction that might affect the diagnosis of rare or atypical cardiac conditions?; How does the performance of Sonic DL vary between 1.5T and 3.0T MR systems, particularly concerning image quality and achievable acceleration factors for different cardiac sequences?; What is the long-term robustness and stability of the Sonic DL algorithm, and what mechanisms are in place for retraining or updating the model as new data or imaging techniques emerge?

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(deep learning, algorithm, retraining)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials
- Not detected
HBOMHardware Bill of Materials(hardware)
✓ 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, HBOM 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, SaaSBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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Sonic DL - GE Medical Systems,LLC (GE Healthcare) | ESL FDA AI Device Intelligence