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

    TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM

    K Number: K101861 · Decision Dec 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    1
    Review Days
    173

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
    K Number
    K101861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Truevision Systems, Incorporated
    Date Received
    July 2, 2010
    Decision Date
    December 22, 2010
    Product Code
    HKI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HKI Camera, Ophthalmic, Ac-Powered

    Similar 510(k) Clearances

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

    Eyer 2

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Fundus On Phone Non Mydriatic (FOP NM-10)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Optina-4C (MHRC-C1N)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    3nethra neo HD FA; 3nethra neo HD

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Resolve Fundus Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Sentinel Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all