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

    FLUOROPRO RF DIGITAL IMAGING SYSTEM

    K Number: K070390 · Decision Apr 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    5
    Review Days
    55

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    Basic Information

    Device Name
    FLUOROPRO RF DIGITAL IMAGING SYSTEM
    K Number
    K070390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Virtual Imaging, Inc.
    Date Received
    February 9, 2007
    Decision Date
    April 5, 2007
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Virtual Imaging, Inc.

    K Number Device Name
    K093688 CANON, MODEL URS-50RF
    K092439 CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
    K092280 CYPHER DICOM PRINT SOLUTION
    K083725 RADPRO ION