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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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Standard Imaging QA Pilot is cloud-based software tool that allows users to enter, store, and analyze data accumulated in the clinical radiation oncology setting from quality assurance processes.
STANDARD IMAGING INC.
91348
In Commercial Distribution

  • 00866562000298 ()
91348

  • Radiation therapy software
No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software
The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
2.18.2
In Commercial Distribution

  • 00860011623915 ()


  • Radiological PACS software
NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is designed to address a patient’s difficulty with eye movement and the integration of visual information. The therapy re-trains the patient’s ability to scan the environment, re-integrate left and right vision, and make the most of their remaining visual field. NeuroeyeCoach is self-adaptive and adjusts the task difficulty to the patient's deficit and stage of recovery while encouraging eye movement efficiency.
Novavision, Inc.
NEC 2.00
In Commercial Distribution

  • 00860010599716 ()


  • Vision training software
VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
Novavision, Inc.
VRT 7.0
In Commercial Distribution

  • 00860010599709 ()


  • Vision training software
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586349 ()


  • Radiological PACS software
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


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

  • 00860003376119 ()


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

  • 00860003376102 ()


  • Vision self-testing software
Submission for Philips FetView version 1.10.0 Initial release
Philips Ultrasound LLC
795268
In Commercial Distribution

  • 00884838115958 ()


  • Radiological PACS software
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