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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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EasyViz - 00628105001021

EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.
Canon Medical Informatics A/S
8.3.9
In Commercial Distribution

  • 00628105001021 ()


  • Radiological PACS software

Vitrea Read - 00628105001007

Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.
Canon Medical Informatics A/S
8.4
In Commercial Distribution

  • 00628105001007 ()


  • Radiological PACS software

myVisionTrack - 00860003376157

Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software

myVisionTrack - 00860003376119

Vision testing application - HCP Portal
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376119 ()


  • Vision self-testing software

myVisionTrack - 00860003376102

Vision testing application - android version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376102 ()


  • Vision self-testing software

Overjet DI System - 00860005586349

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586349 ()


  • Radiological PACS software

Mimics Flow - 05404028000908

Mimics Flow
Materialise NV
Mimics Flow
In Commercial Distribution

  • 05404028000908 ()
Mimics Flow

  • CAD/CAM software

Mimics Flow - 05404028000632

Mimics Flow
Materialise NV
Mimics Flow
In Commercial Distribution

  • 05404028000632 ()
Mimics Flow

  • CAD/CAM software

SurgiCase OOS - 05404028000281

SurgiCase Mobile
Materialise NV
SurgiCase Mobile
In Commercial Distribution

  • 05404028000281 ()
SurgiCase Mobile

  • CAD/CAM software

Grin Website - D962GGW00001

No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGW00001 ()


  • Radiological PACS software
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