SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd. • Radiology • 04/15/2025
Device Purpose
The Arineta SpotLight / SpotLight Duo is a Computed Tomography X-Ray System designed for low dose lung cancer screening across various patient sizes. Its approval for marketing and expanded use in small patients (50-70 kg) is based on demonstrating substantial equivalence to predicate devices and confirming diagnostic image quality and nodule detectability through bench and clinical assessments, without requiring hardware changes.
Summary
Arineta Ltd.'s SpotLight / SpotLight Duo, a Computed Tomography X-Ray System designed for Low Dose Lung Cancer Screening, received regulatory determination on April 15, 2025, allowing its marketing. This approval was granted after the device was found substantially equivalent to existing predicate devices, confirming its compliance with general regulatory provisions, including annual registration, device listing, good manufacturing practices, and precise labeling. The system's core technological characteristics remain consistent with its predicates, ensuring its fundamental design and performance align with established standards.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. What specific imaging parameters and reconstruction algorithms are optimized for the 50-70 kg patient group to achieve diagnostic quality at low dose?; What were the quantitative and qualitative metrics used in the clinical image assessments to confirm diagnostic quality and nodule detectability for small patients?; How does the SpotLight system's performance in terms of image noise, spatial resolution, and artifact reduction compare to its predicate devices across all cleared patient sizes?; Were any specific challenges or limitations observed during the clinical image assessment of small patients, particularly concerning very small or sub-solid nodules?; What are the long-term data collection plans or post-market surveillance strategies to continually evaluate the clinical utility and safety of the low-dose lung cancer screening option in diverse patient populations?
Risk Classification
ESL AnalysisFDA 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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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, HBOM detected in AI-generated device summary.
• 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, SaaSBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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