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

    STEREOTIX

    K Number: K873618 · Decision Nov 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    3
    Review Days
    69

    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
    STEREOTIX
    K Number
    K873618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Thomson-Cgr Medical Corp.
    Date Received
    September 8, 1987
    Decision Date
    November 16, 1987
    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.

    SMART FINDER

    FDA 510(k)
    FDA Class 2 ·Radiology

    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
    View all

    Other Clearances by Thomson-Cgr Medical Corp.

    K Number Device Name
    K873544 MPG-50 X-RAY GENERATOR
    K852353 DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM