BEUDAMED
    Product Code: NFI FDA class 2 21 CFR 892.2040

    Device, Hardcopy, Images, Ophthalmic

    Radiology

    The Device, Hardcopy, Images, Ophthalmic (product code NFI) is a radiology/ophthalmic device used to produce printed or hardcopy output of ophthalmic diagnostic images, such as fundus photographs or optic nerve images. It is classified as an FDA Class 2 device within the Radiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NFI
    Device Class
    FDA class 2
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.