ClariCT.AI

GUDID 08800046800136

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. The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer. The subject device, ClariCT.AI, added a new module (named AI Marketplace Integration module) to the original cleared device (K183460) to enable installation on the AI Marketplace system. The module integrates the Denoising Processor of original device into the AI Marketplace system. ClariCT.AI, consists only of the AI Marketplace Integration Module and the Denoising Processor, can be installed in the AI Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An AI Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based AI platform service that connects end users (e.g. hospitals, imaging centers) and AI medical imaging applications developed by third parties. These AI Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party AI applications. With the newly added module, ClariCT.AI will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interface.

ClariPI Inc.

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• Primary Device ID: 08800046800136
• NIH Device Record Key: 102ef6a0-3069-4409-8c67-8d1deabb3d74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariCT.AI
• Version Model Number: 1.3.3
• Company DUNS: 693744312
• Company Name: ClariPI Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800046800136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212074

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-06
• Device Publish Date: 2023-08-29

On-Brand Devices [ClariCT.AI]

• 08800046800136: ClariCT.AI, is a software device intended for networking, communication, processing and enhancem
• 08800046800006: 1.1.0