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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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Clinical image viewer
ULTRARAD CORPORATION
2.0.0.0
In Commercial Distribution

  • 00860001148503 ()


  • Radiological PACS software
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
DI DLS
Ortho2, LLC
6.1.1
In Commercial Distribution

  • 00860001048506 ()


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

  • 00860007887116 ()


  • Vision training software
No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution

  • 00860007318764 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution

  • 00860007318740 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution

  • 00860007318726 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-10
Not in Commercial Distribution

  • 00860007318702 ()


  • Cognitive assessment software
No Description
Aiq Global, Inc.
2.x
In Commercial Distribution

  • 00860007104916 ()


  • Radiological PACS software
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
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