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

    PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).

    K Number: K070664 · Decision Apr 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    48

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    Basic Information

    Device Name
    PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
    K Number
    K070664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Progeny, Inc.
    Date Received
    March 9, 2007
    Decision Date
    April 26, 2007
    Product Code
    MUH
    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
    MUH System, X-Ray, Extraoral Source, Digital

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    Other Clearances by Progeny, Inc.

    K Number Device Name
    K090079 VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
    K043092 PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
    K041831 PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
    K020070 JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002