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

    dS Breast Coil 7ch 1.5T

    K Number: K232762 · Decision Oct 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    6
    Review Days
    25

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    Basic Information

    Device Name
    dS Breast Coil 7ch 1.5T
    K Number
    K232762
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invivo Corporation (Business Trade Name: Philips)
    Date Received
    September 8, 2023
    Decision Date
    October 3, 2023
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Invivo Corporation (Business Trade Name: Philips)

    K Number Device Name
    K222325 8ch Wrist Coil
    K222257 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
    K213735 dS Sentinelle Breast 16ch 1.5T Coil
    K213727 dS Sentinelle Breast 16ch 3.0T Coil
    K213351 ds Head 32ch 3.0T