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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

UltraVISION - 00860001148503

Clinical image viewer
ULTRARAD CORPORATION
2.0.0.0
In Commercial Distribution

  • 00860001148503 ()


  • 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

SmartCeph - 00860001048506

DI DLS
Ortho2, LLC
6.1.1
In Commercial Distribution

  • 00860001048506 ()


  • Radiological PACS 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

Luminopia - 00860007887123

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887123 ()


  • Vision training software

Luminopia - 00860007887116

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887116 ()


  • Vision training software

Luminopia - 00860007887109

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887109 ()


  • Vision training software
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