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

    LIGHTLINE-M

    K Number: K974240 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    40

    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
    LIGHTLINE-M
    K Number
    K974240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wuestec Medical, Inc.
    Date Received
    November 12, 1997
    Decision Date
    December 22, 1997
    Product Code
    IZX
    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
    IZX Collimator, Manual, Radiographic

    Similar 510(k) Clearances

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

    RALCO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-20J

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-20J

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-30H

    FDA 510(k)
    FDA Class 2 ·Radiology

    FACTS MONOBLOCK

    FDA 510(k)
    FDA Class 2 ·Radiology

    AXT 150M MANUAL COLLIMATOR (AXT 150M)

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

    Other Clearances by Wuestec Medical, Inc.

    K Number Device Name
    K993962 PENSIL TRAUMA, MODEL WWS6100
    K992603 XRT 600 R/F, WRF 0600
    K992103 C-QUEST
    K981880 DX-480, ADD ON DIGITAL IMAGER
    K955414 XRT 400
    K960083 MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
    K935123 SUPERSTAND 300
    K933253 SUPERSTAND 3000