BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEDICAL X-RAY FILM

    K Number: K860797 · Decision Mar 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    9

    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
    MEDICAL X-RAY FILM
    K Number
    K860797
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    India-America Trading Co.
    Date Received
    March 4, 1986
    Decision Date
    March 13, 1986
    Product Code
    IWZ
    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
    IWZ Film, Radiographic

    Similar 510(k) Clearances

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

    KODAK EKTASIAN HG FILM (EHG-15)

    FDA 510(k)
    FDA Class 1 ·Radiology

    VOXGRAM

    FDA 510(k)
    FDA Class 1 ·Radiology

    3M MEDICAL DIAGNOSTIC VIDEOCASSETTE

    FDA 510(k)
    FDA Class 1 ·Radiology

    3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE

    FDA 510(k)
    FDA Class 1 ·Radiology

    ORWO X-RAY FILM

    FDA 510(k)
    FDA Class 1 ·Radiology

    KODAK DENTAL BARRIER PAC

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all