BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SubtleMR

    K Number: K191688 · Decision Sep 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    8
    Review Days
    84

    Basic Information

    Device Name
    SubtleMR
    K Number
    K191688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Subtle Medical, Inc.
    Date Received
    June 24, 2019
    Decision Date
    September 16, 2019
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by Subtle Medical, Inc.

    K Number Device Name
    K243250 SubtleHD (1.x)
    K240290 AiMIFY (1.x)
    K241329 SubtleSYNTH (1.x)
    K233699 SubtleREFORMAT (1.x)
    K211964 SubtlePET
    K203182 SubtleMR
    K182336 SubtlePET