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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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The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.
Carl Zeiss Meditec, Inc.
500
In Commercial Distribution

  • 04057748096037 ()


  • Ophthalmic fundus camera
No Description
Aural Analytics, Inc.
SDK
Not in Commercial Distribution

  • 00196852685837 ()


  • Cognitive assessment software
The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam Portable
Not in Commercial Distribution

  • 00899281002137 ()


  • Ophthalmic fundus camera
The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam Shuttle
Not in Commercial Distribution

  • 00899281002120 ()


  • Ophthalmic fundus camera
RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam 3
Not in Commercial Distribution

  • 00899281002113 ()


  • Ophthalmic fundus camera
ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667PROTOZ01 ()
  • B667PROTOZ1 ()


  • Ophthalmic fundus camera
Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667NEXY01 ()
  • B667NEXY1 ()


  • Ophthalmic fundus camera
No Description
Linus Health, Inc.
20005
In Commercial Distribution

  • B626200050 ()
20005

  • Cognitive assessment software
No Description
Linus Health, Inc.
20002
Not in Commercial Distribution

  • B626200020 ()


  • Cognitive assessment software
Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
20001
Not in Commercial Distribution

  • B626200010 ()
20001

  • Cognitive assessment software
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