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510(k) Data Aggregation
K Number
K183059Device Name
3nethra neo
Manufacturer
Date Cleared
2018-12-21
(49 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Forus Health Pvt. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.
Device Description
The 3nethra neo is a compact, portable and easy to use, mydriatic, digital wide field imaging camera used for the photo documentation of ocular diseases that manifest in infant eyes. 3nethra neo needs to be connected to a computer for running the application software, to store, view, retrieve, and export the digital ophthalmic images. The 3nethra neo has a hand-held probe unit, a control box and a foot-pedal control unit. Warm white LED with intensity control via foot-pedal is used to provide illumination to the eye in order to capture images.
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