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3nethra

FORUS HEALTH PRIVATE LIMITED · Model neo P1000 probe · UDI-DI 08908007754044

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Description

The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not provide any analysis or diagnosis. The 3nethra neo has a hand-held probe, a control unit, and a foot pedal. Components such as warm white LEDs, lenses, aperture, sensitive photodetector arrays (CMOS sensor array) are housed in the probe. The light emitted is within the safe limits of group 1 radiant exposure specifications for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the 15004-2 (and ANSI Z80.36-2016) Light Hazard Protection standards for Ophthalmic Instruments. 3nethra neo includes an application software that facilitates the capture, storage, and retrieval of images. Illumination and focus are adjusted using a foot pedal.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.