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

    NORAS MR-BI320-PA 1.5T

    K Number: K081118 · Decision May 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    10
    Review Days
    11

    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
    NORAS MR-BI320-PA 1.5T
    K Number
    K081118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noras Mri Products GmbH
    Date Received
    April 21, 2008
    Decision Date
    May 2, 2008
    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 Noras Mri Products GmbH

    K Number Device Name
    K241069 iLoop Interventional Coil 0.55T
    K220144 Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
    K211658 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
    K180123 Breast BI 7 MR Coil 1.5T Mammavention
    K133506 NORAS OR HEAD HOLDER FLEXIBILITY
    K093693 NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
    K091546 NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
    K083578 NORAS CPC MULTIFUNCTIONAL COIL
    K082373 NORAS MR-BI320-PA 3T