BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

    K Number: K162190 · Decision Jul 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    13
    Review Days
    336

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    Basic Information

    Device Name
    Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
    K Number
    K162190
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Villa Sistemi Medicali S.P.A.
    Date Received
    August 4, 2016
    Decision Date
    July 6, 2017
    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 Villa Sistemi Medicali S.P.A.

    K Number Device Name
    K180601 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
    K130109 ENDOGRAPH DC
    K111152 ROTOGRAPH EVO 3D
    K090749 ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
    K080859 DRF 4343
    K050190 APOLLO
    K030634 ENDOS DC
    K030185 ENDOS AC/ACP
    K002432 STRATO X
    K000412 VISION R/F TILTING TABLE
    Search all 13 clearances from Villa Sistemi Medicali S.P.A. →