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

    BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

    K Number: K903661 · Decision Nov 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    7
    Review Days
    92

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    Basic Information

    Device Name
    BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD
    K Number
    K903661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Bruker Medical Imaging, Inc.
    Date Received
    August 13, 1990
    Decision Date
    November 13, 1990
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by Bruker Medical Imaging, Inc.

    K Number Device Name
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    K913463 MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN
    K900026 BRUKER R28 WHOLE-BODY MR SCANNER
    K895328 MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
    K894714 1989 SOFTWARE REVISION TO THE BMT-1100
    K891760 MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED