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

    TOMi Scope

    K Number: K191804 · Decision Dec 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    TOMi Scope
    K Number
    K191804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Photonicare, Inc.
    Date Received
    July 5, 2019
    Decision Date
    December 5, 2019
    Product Code
    QJG
    Advisory Committee
    Radiology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QJG Device System, Imaging, Tympanic Membrane And Middle Ear

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QJG), ordered by most recent decision date.

    OtoSight Middle Ear Scope

    FDA 510(k)
    FDA Class 2 ·Radiology
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    Other Clearances by Photonicare, Inc.

    K Number Device Name
    K222655 OtoSight Middle Ear Scope