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

    CTL BODY / SPINE ARRAY COIL

    K Number: K014086 · Decision Feb 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    64
    Review Days
    56

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    Basic Information

    Device Name
    CTL BODY / SPINE ARRAY COIL
    K Number
    K014086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Usa Instruments, Inc.
    Date Received
    December 11, 2001
    Decision Date
    February 5, 2002
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Usa Instruments, Inc.

    K Number Device Name
    K052916 USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
    K052621 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
    K052584 1.5T 12 CHANNEL BODY ARRAY
    K052585 3T HD BREAST ARRAY
    K050728 OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
    K042342 MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
    K042186 3.0T 8-CHANNEL CTL SPINE ARRAY
    K042207 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
    K042009 MARK III PHASED ARRAY SHOULDER COIL
    K041695 LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
    Search all 64 clearances from Usa Instruments, Inc. →