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K Number
K102412Device Name
VISTA DIGITAL OPTHALMOSCOPE
Manufacturer
EYEQUICK.LLC
Date Cleared
2011-06-23
(303 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
EYEQUICK.LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
Device Description
The EyeQuick Digital Ophthalmoscope Camera is an ophthalmoscope with an integrated digital camera. The system includes an LCD viewfinder and can be used handheld without any cables. The Digital Ophthalmoscope has on board memory to store images which can be downloaded to a PC via a USB connection.
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