BEUDAMED
    Product Code: LQB FDA class 3

    Medical Computers And Software For Ophthalmic Use

    Unknown

    Medical computers and software for ophthalmic use are electronic systems and associated software specifically designed to assist in the diagnosis, management, or treatment of ophthalmic conditions, including image analysis, diagnostic decision support, or device control in an ophthalmology setting. They are classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) given the potential for patient harm if the software produces erroneous diagnostic output or fails to operate correctly. The product code is LQB; no regulation number or specific medical specialty code is listed for this entry. No special flags apply to this device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    7

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    Basic Information

    Product Code
    LQB
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    3

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K922590 BIO-PEN SRK II CALCULATOR
    K860205 BIO-PEN CALCULATOR