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

    SubtleHD-PET (1.x)

    K Number: K254013 · Decision May 14, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    11
    Review Days
    150

    Basic Information

    Device Name
    SubtleHD-PET (1.x)
    K Number
    K254013
    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
    December 15, 2025
    Decision Date
    May 14, 2026
    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
    K254120 SubtleHD-CT (1.x)
    K243250 SubtleHD (1.x)
    K240290 AiMIFY (1.x)
    K241329 SubtleSYNTH (1.x)
    K233699 SubtleREFORMAT (1.x)
    K223623 SubtleMR (2.3.x)
    K211964 SubtlePET
    K203182 SubtleMR
    K191688 SubtleMR
    K182336 SubtlePET
    Search all 11 clearances from Subtle Medical, Inc. →