AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbHAI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH is software that uses machine learning and deep learning to analyze previously acquired chest CT scans. It helps radiologists and physicians segment lungs and lung lobes, identify and measure solid and sub-solid lung nodules, and track changes over time. This supports clinicians in assessing 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 from specialty care and general practice in the evaluation and assessment of disease of the lungs.
Technology
Uses machine learning and deep learning algorithms to provide quantitative and qualitative analysis from CT DICOM images. Features include segmentation of lungs, lung lobes, parenchyma evaluation, lesion segmentation, correlation with prior scans, and visualization. Deployable on cloud and edge platforms, interfacing with syngo.CT Lung CAD.
Performance
Non-clinical performance testing demonstrated substantial equivalence to predicate device. Lesion segmentation algorithm validated on multi-vendor clinical data from 273 US and 254 German subjects, showing superior or equivalent performance especially for sub-solid nodules. Software verification, usability, cybersecurity testing all conducted successfully.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2023
4 months - 2
FDA Approval
3/21/2024
Other devices from Siemens Healthcare GmbH
- Syngo Carbon Enterprise Access (VA40A)2024 • 510K
- Syngo Carbon Clinicals2023 • 510K
- syngo.CT Lung CAD (Version VD30)2023 • 510K
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