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

    AX-700LE AUTOMATIC X-RAY FILM PROCESSOR

    K Number: K925569 · Decision Jan 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    5
    Review Days
    73

    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
    AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
    K Number
    K925569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alphatek Corp.
    Date Received
    November 3, 1992
    Decision Date
    January 15, 1993
    Product Code
    IXW
    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
    IXW Processor, Radiographic-Film, Automatic

    Similar 510(k) Clearances

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

    XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTRAX FILM PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX

    FDA 510(k)
    FDA Class 2 ·Radiology

    RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000

    FDA 510(k)
    FDA Class 2 ·Radiology

    FILM PROCESSOR, MODEL LIFE RAY PRO 2500

    FDA 510(k)
    FDA Class 2 ·Radiology

    FILM PROCESSOR, MODEL LIFE RAY PRO 1000

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

    Other Clearances by Alphatek Corp.

    K Number Device Name
    K023613 AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
    K931883 AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
    K931882 MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
    K924430 AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027