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510(k) Data Aggregation

    K Number
    K192475
    Device Name
    NemoFAB
    Manufacturer
    Software Nemotec S.L.
    Date Cleared
    2020-04-23

    (226 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NemoFAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NemoFAB is a software indicated for supporting the diagnostic and treatment planning process of orthognathic procedures. NemoFAB is software that is also used as an image segmentation system and for the transfer of imaging information from a scanner such as a CT scanner. NemoFAB allows for the that can be transferred to a 3D printer for the creation of a splint, this splint will be used for aiding the surgeon in the placement of the bones in the orthognathic surgery according to the treatment plan.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text only contains an FDA 510(k) clearance letter and an Indications for Use statement for the NemoFAB device. It does not include information about the acceptance criteria, specific studies, or performance results of the device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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