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510(k) Data Aggregation

    K Number
    K243810
    Device Name
    TraumaCad Neo (1.1)
    Manufacturer
    Brainlab Ltd.
    Date Cleared
    2025-06-04

    (175 days)

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

    Brainlab Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software. The software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.
    Device Description
    TraumaCad Neo 1.1 allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates a film-less orthopedic practice. TraumaCad Neo 1.1 also allows post-operative review and assessment of X-ray images obtained after the surgical procedure, with a feature for automatic surgery outcome analysis of postoperative total hip arthroplasty images. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is communicating with Quentry®, a proprietary web-based cloud service from Brainlab and with other healthcare data platforms, such as PACS solutions. It is through these healthcare data platforms, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.
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    K Number
    K231498
    Device Name
    TraumaCad Neo
    Manufacturer
    Brainlab Ltd.
    Date Cleared
    2023-11-20

    (180 days)

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

    Brainlab Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.
    Device Description
    TraumaCad Neo allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.
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