AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBhAI-Rad Companion (Pulmonary) is AI-powered software that analyzes chest CT scans to help radiologists and clinicians identify and measure lung structures and lesions. It segments lungs and lung lobes, detects lung nodules, compares current images to prior scans for lesion follow-up, and quantifies pulmonary density. These features support the clinical assessment and monitoring of lung diseases, improving workflow efficiency and diagnostic accuracy.
Intended Use
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians in the evaluation and assessment of disease of the lungs.
Technology
The software uses machine and deep learning algorithms to segment lungs, lung lobes, and solid lung nodules from chest CT images. It quantitatively assesses areas of low and high Hounsfield values to evaluate lung parenchyma and pulmonary density. The software provides volumetric and diameter measurements of lesions, correlates current lesions with prior scans for follow-up, and supports cloud and on-premise edge deployment.
Performance
Nonclinical software validation and bench testing demonstrated the software's functional performance and substantial equivalence to predicate devices. Lesion follow-up feature was validated with an algorithm sensitivity of 94.3% and positive predictive value of 99.1% in identifying lesion pairs. The software complies with applicable FDA guidance and recognized consensus standards for medical device software and cybersecurity.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/24/2021
8 months - 2
FDA Approval
8/11/2022
Other devices from Siemens Healthcare GmBh
- Syngo Carbon Enterprise Access (VA40A)2024 • 510K
- AI-Rad Companion (Pulmonary)2024 • 510K
- Syngo Carbon Clinicals2023 • 510K
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