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    K Number
    K223623
    Device Name
    SubtleMR (2.3.x)
    Manufacturer
    Subtle Medical Inc.
    Date Cleared
    2023-05-11

    (157 days)

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

    Subtle Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increase image sharpness for head MRI.
    Device Description
    SubtleMR is Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners. As it only processes images for the end user, the device has no user interface. It is intended to be used by radiologists in an imaging center. clinic, or hospital. The software can be used with MR images acquired as part of MRI exams on 1.2 Tesla, 1.5 Tesla or 3 Tesla scanners. The device's inputs are standard of care MRI images. The outputs are images with enhanced image quality.
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