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

    GX-C CEPHALOMETER

    K Number: K920189 · Decision Apr 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    14
    Review Days
    104

    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
    GX-C CEPHALOMETER
    K Number
    K920189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1830
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gendex Corp.
    Date Received
    January 15, 1992
    Decision Date
    April 28, 1992
    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

    Similar 510(k) Clearances

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

    VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC

    FDA 510(k)
    FDA Class 2 ·Dental

    VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY

    FDA 510(k)
    FDA Class 2 ·Dental

    DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DIGIGRAPH DIAGNOSTIC WORK/STATION

    FDA 510(k)
    FDA Class 2 ·Dental

    BURNETT TMJ APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    GX CEPH

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

    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
    K894188 GX-ELEVATOR
    K890083 GX-2000 STATIONARY X-RAY GENERATOR
    K873982 GX-MOBILE X-RAY UNIT
    Search all 14 clearances from Gendex Corp. →