LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213215
    Device Name
    VSI HoloMedicine
    Manufacturer
    ApoQlar GmbH
    Date Cleared
    2022-11-25

    (422 days)

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

    ApoQlar GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
    Device Description
    VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1