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

    GX CEPH

    K Number: K842463 · Decision Aug 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    14
    Review Days
    41

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    Basic Information

    Device Name
    GX CEPH
    K Number
    K842463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1830
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Gendex Corp.
    Date Received
    June 22, 1984
    Decision Date
    August 2, 1984
    Product Code
    EAG
    Advisory Committee
    Dental
    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
    EAG Cephalometer

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    Other Clearances by Gendex Corp.

    K Number Device Name
    K952598 GX-PAN PANORAMIC DENTAL X-RAY SYSTEM
    K945682 PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
    K935046 GX-770 X-RAY CONTROL, MODEL 46-404600G4
    K925094 VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS
    K931001 ORALIX DC
    K932675 GXP DENTAL X-RAY PROCESSOR
    K922165 ATC725, ATC525, AND AP300
    K920189 GX-C CEPHALOMETER
    K894188 GX-ELEVATOR
    K890083 GX-2000 STATIONARY X-RAY GENERATOR
    Search all 14 clearances from Gendex Corp. →