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ClariCT.AI

FDA UDIEUDAMED

Class II (US FDA UDI)

by ClariPI Inc.

Identity

Trade Name
ClariCT.AI FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
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, has added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of original device into the Al Marketplace system and includes an optional ACE module that additionally improves the CNR of CECT (Contrast-Enhanced CT) images.ClariCT.AI, consists only of the Al Marketplace Integration Module and the Denoising Processor, can be installed in the Al Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An Al Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based Al platform service that connects end users (e.g. hospitals, imaging centers) and Al medical imaging applications developed by third parties. These Al Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party Al applications. With the newly added module, ClariCT.Al 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 interfa FDA UDI
Model / Reference
ClariCT.ACE FDA UDI
Description
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, has added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of original device into the Al Marketplace system and includes an optional ACE module that additionally improves the CNR of CECT (Contrast-Enhanced CT) images.ClariCT.AI, consists only of the Al Marketplace Integration Module and the Denoising Processor, can be installed in the Al Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An Al Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based Al platform service that connects end users (e.g. hospitals, imaging centers) and Al medical imaging applications developed by third parties. These Al Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party Al applications. With the newly added module, ClariCT.Al 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 interfa FDA UDI

Identifiers

Primary DI / UDI-DI
08800046800211 FDA UDI
510(k) Number
K212074 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

ClariCT.AI by ClariPI Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Cleared under the same submission

K212074 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ClariPI Inc.

Sources (2)

  • FDA UDI 1b15f5bb-2c5f-4d62-98c6-67a4b48e0ed8 34 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026