BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Subtle Medical Inc

    Reg #: 3015425142 · FEI: 3015425142 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Subtle Medical Inc
    Registration Number
    3015425142
    FEI Number
    3015425142
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    883 Santa Cruz Avenue, Suite 205
    City
    Menlo Park
    State
    CA
    ZIP
    94025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223623

    Owner / Operator

    Firm Name
    Subtle Medical Inc
    Operator Number
    10060008
    Address
    883 Santa Cruz Avenue, Suite 205
    City
    Menlo Park
    State
    CA
    Postal Code
    94025
    Country
    US

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    SubtleMR SubtleSYNTH SubtlePET AiMIFY SubtleALIGN SubtleREFORMAT SubtleHD SubtleHD-MR SubtleHD(MR)

    Establishment Types

    Manufacture Medical Device