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

    XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM

    K Number: K853459 · Decision Oct 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    75

    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
    XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM
    K Number
    K853459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1630
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Xerox Medical Systems
    Date Received
    August 16, 1985
    Decision Date
    October 30, 1985
    Product Code
    IXK
    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
    IXK System, Imaging, X-Ray, Electrostatic

    Similar 510(k) Clearances

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

    DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    PVMED DDR 2520 DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    RADIOTHERAPY SOLUTION BASED ON CR

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORT CASSETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

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

    Other Clearances by Xerox Medical Systems

    K Number Device Name
    K833243 MAMMOGRAPHIC S-RAY SYSTEM
    K832733 XEROX 120 SYS MAMMOGRAPHIC X-RAY
    K812024 XEROX 128 CASSETTE CHANGER
    K791014 DENTAL XERORADIOGRAPHY