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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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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
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
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software
AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution

  • 10806378054716 ()


  • Orthopaedic implant/instrument assembling device
AI Female Fitting Ass'y nonperm clips
Avalign Technologies, Inc.
M152332
In Commercial Distribution

  • 00190776189648 ()


  • Electrical-only medical device connection cable, reusable
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
SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution

  • 00763000504526 ()


  • Implantable cardiac device management application software
The EPIONE® RoboKit™ is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked.
QUANTUM SURGICAL
09-0057
In Commercial Distribution

  • 03760305400260 ()


  • Surgical optical-tracking spatial marker, single-use
The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
QUANTUM SURGICAL
09-0046
In Commercial Distribution

  • 03760305400253 ()


  • Surgical optical-tracking spatial marker, single-use
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