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uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd. • Radiology • 03/10/2023

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

The uMI Panorama is an advanced hybrid PET/CT imaging system designed to deliver high-quality functional and anatomical images by combining scalable LYSO-based PET technology with a 160-slice CT. It utilizes innovative reconstruction algorithms, including neural network-enhanced and motion-corrected techniques, to aid in comprehensive diagnosis, staging, and treatment evaluation across oncology, cardiology, and neurology, as well as enabling low-dose CT lung cancer screening.

Summary

The uMI Panorama is a diagnostic imaging system that integrates Positron Emission Tomography (PET) and Computed Tomography (CT) functionalities. The PET component measures the quantitative distribution of radiopharmaceuticals within a patient's body to assess metabolic and physiological functions, while the CT component provides diagnostic tomographic anatomical information and photon attenuation data for the scanned region. The system facilitates accurate registration and fusion of PET and CT images, offering an anatomical reference for PET findings. It is intended for use by qualified healthcare professionals in the detection, localization, diagnosis, staging, restaging, treatment planning, and treatment response evaluation across various medical fields including oncology, cardiology, and neurology. Additionally, the CT component can operate independently for single modality diagnostic imaging and is suitable for low-dose CT lung cancer screening to detect early-stage lung nodules. The uMI Panorama system features a choice of 280mm or 350mm axial field of view (AFOV) PET based on 96-ring or 120-ring LYSO detector configurations, respectively, and a 160-slice CT system (uCT ATLAS Astound). Key PET technologies include uExcel Iterative reconstruction, uExcel DPR (which uses pre-trained neural networks for noise reduction and contrast improvement in FDG PET images), and uExcel Focus for respiratory motion correction to improve SUV and lesion volume accuracy. The system boasts a 760mm patient bore and a 318kg maximum table load capacity. The control and reconstruction system manages image acquisition, reconstruction, display, post-processing, data and patient management, and CT dose display.

AI Regulatory Concerns

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

Keywords

PET/CTDiagnostic ImagingEmission Computed TomographyIterative ReconstructionNeural NetworksRespiratory Motion CorrectionAxial Field of View (AFOV)LYSO DetectorOncologyLow-Dose CT Lung Screening

Device Metadata

Submission Number
K223325
Company
Shanghai United Imaging Healthcare Co., Ltd.
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 uExcel DPR (HYPER AiR) neural network-based reconstruction algorithm specifically improve noise reduction and contrast in FDG PET images compared to the uExcel Iterative method alone?; What is the quantitative impact of the uExcel Focus respiratory motion correction on the accuracy of SUV measurements and lesion volume delineation, particularly for small lesions in the thoracic or abdominal regions?; How does the scalable Axial Field of View (280mm vs. 350mm) affect overall scan time and patient throughput for common oncological PET/CT protocols?; What are the specific performance characteristics of the uCT ATLAS Astound 160-slice CT component, particularly regarding low-dose lung cancer screening capabilities and image quality for standalone diagnostic CT?; Can the system's data be integrated with radiation therapy planning systems, and what is the geometric accuracy of the fused PET/CT image set for this purpose?

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 Score15/100
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(neural network, algorithm)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(network)
✓ 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(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, OBOM 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. These may be present in the full FDA submission.

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uMI Panorama - Shanghai United Imaging Healthcare Co., Ltd. | ESL FDA AI Device Intelligence