BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SMART FINDER

    K Number: K203509 · Decision Jul 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    2
    Review Days
    226

    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
    SMART FINDER
    K Number
    K203509
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ims Giotto S.P.A.
    Date Received
    November 30, 2020
    Decision Date
    July 14, 2021
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

    Similar 510(k) Clearances

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

    Affirm Contrast Biopsy

    FDA 510(k)
    FDA Class 2 ·Radiology

    Biopsy Positioner

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affirm Lateral Arm Upright Biopsy Accessory

    FDA 510(k)
    FDA Class 2 ·Radiology

    Comfort Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affirm Prone Biopsy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MammoGRIP

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

    Other Clearances by Ims Giotto S.P.A.

    K Number Device Name
    K200424 Giotto Class (Models - 3000X-YY and 4000X-YY)