ClariCT.AI
ClariPI Inc.ClariCT.AI is a software tool designed to process and enhance CT scan images by reducing noise and improving image clarity. It supports images from various CT scanner manufacturers and helps clinicians by providing improved image quality, especially in low-dose CT scans, facilitating better diagnostic confidence without additional radiation exposure.
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
ClariCT.AI uses pre-trained deep learning models to perform noise reduction and enhance CT images. It can improve image quality of low-dose CT images including filtered back projection and iterative reconstruction images. The system operates by receiving DICOM images, processing them, and transmitting enhanced images to PACS.
Performance
Non-clinical performance testing demonstrated compliance with relevant FDA-recognized consensus standards and guidance, using ACR CT accreditation phantom, various clinical datasets with different doses, scan conditions, and patient demographics. No clinical studies were required to establish substantial equivalence. Verification and validation testing confirmed safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2018
6 months - 2
FDA Approval
6/13/2019
Other devices from ClariPI Inc.
- ClariPulmo2022 • 510K
- ClariSIGMAM2021 • 510K
- ClariCT.AI2021 • 510K
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