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510(k) Data Aggregation

    K Number
    K203651
    Device Name
    Cuptimize
    Manufacturer
    Cuptimize, Inc.
    Date Cleared
    2021-02-26

    (74 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cuptimize, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cuptimize is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component. It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
    Device Description
    Cuptimize is a software as a medical device (SaMD) system that provides acetabular component position data for hip replacement surgery. The software guides the user through a workflow that olves positioning a series of digital annotations on preoperative and intraoperative radiographic images. This enables the system to calculate inclination and anteversion data that describes the acetabular component position.
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