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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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NANO-X AI LTD
1.0.6
Not in Commercial Distribution

  • 07290018016015 ()


  • Radiology DICOM image processing application software
No Description
NANO-X AI LTD
3.0.0
Not in Commercial Distribution

  • 07290018016008 ()


  • Radiology DICOM image processing application software
An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.
Terarecon Inc.
Eureka AI Interoperability Platform
In Commercial Distribution

  • B220843002A8430031 ()


  • Radiological image interpretive software sharing portal
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment. The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI. While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools. Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
ClariPI Inc.
ClariSuite View
In Commercial Distribution

  • 08800046800167 ()


  • Radiological image interpretive software sharing portal
ClariPlatform (Ver. 1.0) is a medical imaging platform that hosts clinical AI solutions in a cloud-based SaaS format. The system facilitates the networking, filtering, routing, and de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. ClariPlatform is only deployed on the cloud, ensuring accessibility and compliance with regulations. Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
ClariPI Inc.
1.0
In Commercial Distribution

  • 08800046800150 ()


  • Radiological image interpretive software sharing portal
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software
AI Female Fitting Ass'y nonperm clips
Avalign Technologies, Inc.
M152332
In Commercial Distribution

  • 00190776189648 ()


  • Electrical-only medical device connection cable, reusable
AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution

  • 10806378054716 ()


  • Orthopaedic implant/instrument assembling device
FIBEROPTIC LIGHT CABLE ADAPTER FOR AI
Avalign Technologies, Inc.
72-52310
In Commercial Distribution

  • 00190776208738 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution

  • 00763000504533 ()


  • Implantable cardiac device management application software
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