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510(k) Data Aggregation
K Number
K231230Device Name
Optina-4C (MHRC-C1N)
Manufacturer
Optina Diagnostics Inc.
Date Cleared
2023-12-05
(221 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Optina Diagnostics Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
Device Description
Optina-4C™ (model: MHRC-C1N) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm.
Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15 diopters. The images are displayed on a monitor and can be saved on the computer for future consultation.
The illumination light of Optina-4C™ is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms.
The 92 images can be visualized one by one in Optina-4C™ acquisition software. The retinal images captured by Optina-4C™ are monochromatic images having a spectral bandwidth of "10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.
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K Number
K200254Device Name
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Manufacturer
Optina Diagnostics
Date Cleared
2020-04-27
(84 days)
Product Code
HKI, NFJ
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Optina Diagnostics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
Device Description
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of 92 images of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm.
Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15 diopters. The images are displayed on a monitor and can be saved on the computer for future consultation.
The illumination light of the MHRC-C1 is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm to 450 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms.
The 92 images can be visualized one by one in the MHRC-C1 acquisition software. The retinal images captured by the MHRC-C1 are monochromatic images having a spectral bandwidth of ~10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.
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