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510(k) Data Aggregation

    K Number
    K222998
    Device Name
    F3
    Date Cleared
    2023-06-20

    (265 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Acrew Imaging, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    F3 provides image guidance by overlaying a previously constructed preoperative vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices. F3 is intended to assist fluoroscopy-guided endovascular procedures in the thorax. Suitable procedures include endovascular aortic aneurysm repair (AAA and mid-distal TAA) and angioplasty. F3 i not intended for use in the X-Ray guided procedures in the liver, kidneys or pelvic organs.
    Device Description
    The purpose of F3 is to assist the user with the visual evaluation, comparison, and merging of information between anatomical and functional images from a single patient. The user needs to take into consideration the product's limitations and accuracy when integrating the information from the registration results for final interpretation. F3 does not replace the usual procedures for visual comparison of datasets by a user. Fusion images are intended to provide additional information to a user's existing workflow for patient evaluation. F3 offers: - Visualization of multi-modality image data - Automatic registration - Import of DICOM data - Capture of fluoroscopic image frames
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