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510(k) Data Aggregation

    K Number
    K252120

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (158 days)

    Product Code
    Regulation Number
    886.1120
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FOP NM-10 is an ophthalmic non-mydriatic digital camera using iPhone SE3 which captures images of the fundus of the human eye and surface as well as surrounding areas of the human eye.

    Device Description

    The FOP NM-10 is designed for imaging of the fundus and surface as well as surrounding area of the human eye, in a compact, portable format, with an inherent simplicity built in its operation and use. The application software (Remidio FOP) is loaded on top of the iOS operating system to enable the user to view, save, archive and retrieve the captured images of fundus and surface area of the human eye. It is a compact, battery-operated device that enables high-quality fundus photography without requiring pupil dilation. The device can be used in Hospitals and Ophthalmic clinics. The FOP NM-10 incorporates a 40° field of view (FOV) optical system optimized for high-resolution retinal imaging. The device employs infrared and white LED illumination to achieve adequate retinal illumination without causing discomfort to the patient. The device is built on a modular smartphone-based design, ensuring portability and ease of operation. The Remidio FOP app enables wireless control of illumination intensity, focus adjustments, capturing the images in Auto and manual modes, saving, editing and archiving images.

    Physical Specifications

    • a) Field of View: 40° (for a minimum pupil size of 3mm)
    • b) Material: ABS, Silicone Rubber
    • c) Diopter Correction: -16D to +16D
    • d) Working Distance: 33mm

    Output and Performance Characteristics

    • a) Illumination (Light Source): Infrared LED and Cool White LED
    • b) Camera Resolution: 64 line pairs per millimeter (lp/mm) (at the center)
    • c) ISO Range: ISO 200 and 400
    • d) Focus Adjustment: Manual and Tap to Focus
    • e) Internal Fixation: 8 fixation points
    • f) Operating temperature: 10° to 40°C
    • g) Relative Humidity: 10% to 85%
    • h) Atmospheric Pressure: 750 to 1060 hpa
    AI/ML Overview

    N/A

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