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510(k) Data Aggregation

    K Number
    K193499
    Device Name
    DigiGuide System
    Manufacturer
    ProtoMED, Inc.
    Date Cleared
    2020-11-04

    (323 days)

    Product Code
    DZJLLZ
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ProtoMED, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ProtoMED DigiGuide System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DigiGuide System and the result is an output data file that is used as the input to a rapid prototyping portion of the system that produces physical outputs including templates for use in maxillofacial surgery. The DigiGuide System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
    Device Description
    The ProtoMED DigiGuide System consists of a digital surgical plan (DigiPlan), applicable DigiGuide Templates, and optional anatomical models in order to plan and implement a maxillofacial surgery.
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