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

    MARK III PHASED ARRAY SHOULDER COIL

    K Number: K042009 · Decision Aug 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    64
    Review Days
    16

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MARK III PHASED ARRAY SHOULDER COIL
    K Number
    K042009
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Usa Instruments, Inc.
    Date Received
    July 26, 2004
    Decision Date
    August 11, 2004
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MOS), ordered by most recent decision date.

    0.55T 12Ch Breast Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    HD 8Ch Wrist Array

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

    FDA 510(k)
    FDA Class 2 ·Radiology

    Smart Fit TorsoCardiac 1.5T

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only

    FDA 510(k)
    FDA Class 2 ·Radiology

    3.0T AIR 32CH HNA

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    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
    K041695 LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
    K041487 QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
    Search all 64 clearances from Usa Instruments, Inc. →