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510(k) Data Aggregation

    K Number
    K241280
    Device Name
    Constellation (CON-001)
    Manufacturer
    Date Cleared
    2024-09-12

    (128 days)

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

    Q Bio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions. Constellation utilizes DICOM MR images gathered on a GE MR450W that encompass the whole-body. It is intended to be used for healthy adult patients. Clinicians may use Constellation as a clinical decision support tool, but it is not to be used in triage events, emergency medicine, or critical care. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices.
    Device Description
    Constellation is an automated image post-processing software application used in a clinical MRI setting. Constellation combines MR images from overlapping anatomical stations to segment anatomical regions and provide associated quantitative measurements for whole-body patient anatomy. These anatomical regions include the lower limb muscles, visceral adipose tissue, subcutaneous adipose tissue, kidneys, liver, spleen, lungs, and brain structures. A PDF report contains quantified measurements alonqside a whole-body visualization and segmented label images. Constellation provides alpha-blending of the anatomical image with the corresponding labels in the final report. This process combines one stitched output (background) with another (foreground) to create a final anatomical label with both grayscale and color resulting from the blending of the background (greyscale) and foreground label. Constellation is a tool intended to assist trained physicians in the assessment of MR images of the whole body. The software is not designed to provide any automated detection or diagnosis. Physicians retain the ultimate responsibility for making any diagnosis from the presented images based on their standard practices and patient background, clinical history, symptoms, and other diagnostic information.
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