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

    SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM

    K Number: K791812 · Decision Nov 5, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    9
    Review Days
    48

    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
    SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
    K Number
    K791812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Spectrum X-Ray Corp.
    Date Received
    September 18, 1979
    Decision Date
    November 5, 1979
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

    Similar 510(k) Clearances

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

    VISION R/F TILTING TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEGACY/LEGACY-D TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAP-35B III/CINE 275

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS EASY DIAGNOST

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECTROPHYSIOLOGY TILT TABLE MODEL #9660

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLUOROVIEW SERIES FLUOROSCOPIC TABLES

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

    Other Clearances by Spectrum X-Ray Corp.

    K Number Device Name
    K933134 SPECTRUM DG-P7000 PEDIATRIC CRADLE
    K931563 SPECTRUM MARK I SPECIAL PROCEDURES TABLE
    K870707 PENTAMAX 1 MODEL B TABLE SYSTEM
    K834494 SPECTRUM X-RAY CORP
    K840463 DIGITAL CRADLE
    K827450 SIMPLAMATIC III
    K813561 SPECTRUM PEDIATRIC CARDLE TABLE
    K791811 SPECTRUM AUTOMATIC CHEST UNIT MODEL C