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

    POLAROID TPX RADIOGRAPHIC FILM

    K Number: K811352 · Decision Jun 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    35

    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
    POLAROID TPX RADIOGRAPHIC FILM
    K Number
    K811352
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Polaroid Corp.
    Date Received
    May 14, 1981
    Decision Date
    June 18, 1981
    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

    Other Clearances by Polaroid Corp.

    K Number Device Name
    K812542 POLAROID INSTANT ENDOCAMERA
    K812088 POLAROID RADIOGRAPHIC FILM PROCESSOR
    K812089 POLAROID RADIOGRAPHIC FILM CASSETTE
    K792512 POLAROID LAND CAMERA FOR ENDOSCOPY