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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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UltraDISTRIBUTOR - 00860001148510

Allows sites a methodology to securely deliver electronic results and images to their referring physicians
ULTRARAD CORPORATION
1.0.0.2
In Commercial Distribution

  • 00860001148510 ()


  • Radiological PACS software

IRIS - 00860001130508

The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam.
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
3.0
In Commercial Distribution

  • 00860001130508 ()


  • Ophthalmology PACS software

Brain Gauge MD - 00860000709408

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software

Cognivue Thrive - 00860000564052

No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564052 ()


  • Cognitive assessment software

Cognivue Thrive - 00860000564038

No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564038 ()


  • Cognitive assessment software

Cognivue Advanced Desktop - 00860000564014

No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution

  • 00860000564014 ()


  • Cognitive assessment software

ProKnow DS - 00860000358705

ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.
PROKNOW, LLC
1.0
In Commercial Distribution

  • 00860000358705 ()


  • Radiological PACS software

Aqua - 00858164002381

No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software

Monaco - 00858164002275

No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 00858164002275 ()


  • Radiation therapy software

Monaco - 00858164002268

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002268 ()


  • Radiation therapy software
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