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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 Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).
NIDEK CO.,LTD.
Mirante
In Commercial Distribution

  • 04987669101568 ()


  • Scanning-laser retinal imaging system
  • Retinal optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V.7.2-US with Heidelberg Eye Explorer
In Commercial Distribution

  • 04059237001034 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V.7.2-US
In Commercial Distribution

  • 04059237001027 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S2002
In Commercial Distribution

  • 04059237000891 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S1002
In Commercial Distribution

  • 04059237000884 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V7.0-US
In Commercial Distribution

  • 04059237000839 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V7.0-US
In Commercial Distribution

  • 04059237000815 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S2610 [SN>20000]
In Commercial Distribution

  • 04059237000792 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S3610 [SN>20000]
In Commercial Distribution

  • 04059237000723 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2001A [>20000]
In Commercial Distribution

  • 04059237000716 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
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