BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL

    K Number: K072909 · Decision Oct 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    31
    Review Days
    19

    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
    1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
    K Number
    K072909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens AG Medical Solutions
    Date Received
    October 12, 2007
    Decision Date
    October 31, 2007
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 Siemens AG Medical Solutions

    K Number Device Name
    K143196 syngo.CT Lung CAD
    K130998 SYNGO.VIA WEB VIEWER
    K123920 SYNGO.VIA
    K120331 SYNGO CT DYNAMIC ANGIO
    K111079 SYNGO.VIA WEB VIEWER
    K101666 SYNGO. PLAZA VA20A
    K100637 SYNGO.CT CORONARY ANALYSIS
    K093612 SYNGO.PLAZA
    K092067 ABVS WORKPLACE
    K092519 SYNGO.X
    Search all 31 clearances from Siemens AG Medical Solutions →