Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900041 ()


  • Radiology DICOM image processing application software
The Rconsole1 is intended for use with mammographic images acquired using digital breast x-ray systems.
DRTECH Corporation
1.0
In Commercial Distribution

  • 08800018411001 ()


  • Radiology DICOM image processing application software
The EConsole1 is indicated for use in general radiographic images of human anatomy.
DRTECH Corporation
EConsole1
In Commercial Distribution

  • 08800018410004 ()


  • Radiology DICOM image processing application software
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 multiframe PET-CT module which denoises multiframe PET-CT fusion images included as a series in CT study. 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 interface.
ClariPI Inc.
ClariPET-CT
In Commercial Distribution

  • 08800046800228 ()


  • Radiology DICOM image processing application software
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
ClariPI Inc.
ClariCT.ACE
In Commercial Distribution

  • 08800046800211 ()


  • Radiology DICOM image processing application software
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.
1.3.3
In Commercial Distribution

  • 08800046800136 ()


  • Radiology DICOM image processing application software
ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abnormalities. The software is designed to support the physician in quantification of physicianidentified lung Abnormalities. The software will provide automated segmentation of the lungs and quantification of low-attenuation and high-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and identified Abnormality. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung Abnormalities in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.
ClariPI Inc.
2.0.1
In Commercial Distribution

  • 08800046800020 ()


  • Radiology DICOM image processing application software
No Description
ClariPI Inc.
1.1.0
In Commercial Distribution

  • 08800046800006 ()


  • Radiology DICOM image processing application software
Vesion 2.8.6
Densitas Incorporated
2.x.y
In Commercial Distribution

  • 00628678950047 ()


  • Radiology DICOM image processing application software
Version 2.8.5
Densitas Incorporated
2.x.y
Not in Commercial Distribution

  • 00628678950030 ()


  • Radiology DICOM image processing application software
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