ClariCT.AI
ClariPi Inc.ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.
Intended Use
ClariCT.AI is a software device intended for networking, communication, processing, and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.
Technology
The device uses pre-trained deep learning models to perform noise reduction in CT images, improving image quality particularly for low-dose acquisitions. It can process images in both Windows and Linux environments, integrates with AI Marketplace systems for centralized PACS communication, and supports GPU computing via CUDA.
Performance
Non-clinical performance testing verified compliance with international standards on risk management, DICOM standards, software content guidance, cybersecurity, and interoperability. Testing demonstrated the device meets acceptance criteria for safety and effectiveness with no clinical study required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/2/2021
25 days - 2
FDA Approval
7/27/2021
Other devices from ClariPi Inc.
- ClariPulmo2022 • 510K
- ClariSIGMAM2021 • 510K
- ClariCT.AI2019 • 510K
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