Omni Legend

GE Medical Systems Israel, Functional Imaging • Radiology • 08/08/2024

510(k)IEC 62304 Class B

Device Purpose

The Omni Legend is a hybrid digital PET/CT system designed to provide comprehensive diagnostic imaging by assessing metabolic and physiologic function across various body regions. It employs an "Enhanced AC" software option to correct image attenuation artifacts due to respiratory motion, with its substantial equivalence affirmed through rigorous non-clinical testing and clinical evaluation.

Summary

The Omni Legend, a medical imaging system developed by GE Medical Systems Israel, is a Positron Emission Tomography/Computed Tomography (PET/CT) system found substantially equivalent to existing market devices. It is designed for qualified healthcare professionals to image the distribution and localization of positron-emitting radiopharmaceuticals, assessing metabolic and physiologic function across all patient ages and sizes. The system supports whole-body imaging, including specific organs like the heart, brain, and lungs, aiding in diagnosis, staging, monitoring, and treatment planning in oncology, cardiology, and neurology. This hybrid digital PET/CT diagnostic imager integrates a GEHC PET System with a diagnostic CT System, featuring an "Enhanced AC" software option to correct image attenuation artifacts caused by natural respiratory motion. Its substantial equivalence was determined through comprehensive non-clinical design control testing, adherence to international standards such as IEC 60601-1 and NEMA NU 2-2018, and a clinical reader study. These evaluations collectively confirmed that the Omni Legend's technological characteristics introduce no new safety or effectiveness concerns compared to legally marketed devices.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Omni LegendPET/CT systemPositron Emission TomographyComputed TomographyAttenuation correctionRespiratory motionMedical imagingDiagnostic imagerSubstantial equivalenceRadiopharmaceuticals

Device Metadata

Submission Number

K241665

Company

GE Medical Systems Israel, Functional Imaging

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. How does the "Enhanced AC" software specifically improve image quality compared to previous iterations or competitor devices, particularly in regions affected by significant respiratory motion?; What specific clinical scenarios or patient populations are expected to benefit most from the Omni Legend's whole-body imaging capabilities and enhanced attenuation correction?; Beyond substantial equivalence, are there any preliminary data or ongoing studies evaluating the long-term clinical outcomes or impact on patient management associated with using the Omni Legend system?; What were the quantitative metrics used in the clinical reader study to determine the effectiveness and safety of the device, especially concerning the "Enhanced AC" feature?; Could the system's ability to image various organ systems lead to novel diagnostic applications or research avenues, particularly in multi-organ diseases?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

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 Score15/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan✓ Detected in Summary

§524B ApplicableYes

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

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not 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.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Not detected in AI-generated device summary: SBOM, ML-BOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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