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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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AEYE Health - 00850035651032

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
In Commercial Distribution



  • Retinal image analysis software

AEYE Health - 00850035651018

AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
Aeye Health, Inc.
AEYE-DS-Epic
Not in Commercial Distribution

  • 00850035651018 ()


  • Retinal image analysis software

AEYE Health - 00850035651001

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution

  • 00850035651001 ()


  • Retinal image analysis software

Automated Wound Measurements - 00860475000383

No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution

  • 00860475000383 ()


  • Wound management image-analysis software

EyeArt - 00860000470001

No Description
Eyenuk, Inc.
2.1.0
In Commercial Distribution

  • 00860000470001 ()


  • Retinal image analysis software

IDx-DR - 00860005195626

No Description
Digital Diagnostics Inc.
v2.3
In Commercial Distribution

  • 00860005195626 ()


  • Retinal image analysis software

IDx-DR - 00860005195619

No Description
Digital Diagnostics Inc.
V2
In Commercial Distribution

  • 00860005195619 ()


  • Retinal image analysis software

Welch Allyn, Inc. - 00732094223910

RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution

  • 00732094223910 ()
411215

  • Retinal image analysis software

AEYE Health - 00085003651039

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution



  • Retinal image analysis software

AEYE Health - 00085003651022

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution



  • Retinal image analysis software
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