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

    LCR GENERATOR

    K Number: K931998 · Decision Jul 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    190
    Review Days
    95

    Basic Information

    Device Name
    LCR GENERATOR
    K Number
    K931998
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    April 23, 1993
    Decision Date
    July 27, 1993
    Product Code
    IZO
    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
    IZO Generator, High-Voltage, X-Ray, Diagnostic

    Similar 510(k) Clearances

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

    MPH50, MPH65, AND MPH80

    FDA 510(k)
    FDA Class 1 ·Radiology

    HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    N 800 HF

    FDA 510(k)
    FDA Class 1 ·Radiology

    SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G

    FDA 510(k)
    FDA Class 1 ·Radiology

    MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    POLYDOROS SX 65 AND 80

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

    Other Clearances by Philips Medical Systems (Cleveland), Inc.

    K Number Device Name
    K171850 Philips CT Big Bore
    K172406 Ingenuity TF
    K162838 Philips iCT CT System
    K163711 IQon Spectral CT
    K170086 Pinnacle Radiation Therapy Planning System
    K160743 Philips Ingenuity CT
    K153444 Philips Multislice CT System with Low Dose CT Lung Cancer
    K130992 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
    K111336 EBW NM 2.0
    K111024 JETPACK 2.0
    Search all 190 clearances from Philips Medical Systems (Cleveland), Inc. →