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510(k) Data Aggregation

    K Number
    K221943
    Device Name
    EmbedMed
    Manufacturer
    3D LifePrints UK Ltd.
    Date Cleared
    2023-02-01

    (211 days)

    Product Code
    PBF
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    3D LifePrints UK Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K220366
    Device Name
    EmbedMed
    Manufacturer
    3D LifePrints UK Ltd.
    Date Cleared
    2022-09-30

    (234 days)

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

    3D LifePrints UK Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EmbedMed 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 is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
    Device Description
    EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to create digital and additive manufactured, patient-specific physical anatomical models and surgical guides for use in surgical procedures. Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).
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