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

    ECHELON SPECTROSCOPY PACKAGE

    K Number: K071506 · Decision Jun 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    9
    Applicant Total
    100
    Review Days
    27

    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
    ECHELON SPECTROSCOPY PACKAGE
    K Number
    K071506
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Systems America, Inc.
    Date Received
    June 1, 2007
    Decision Date
    June 28, 2007
    Product Code
    LNI
    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
    LNI System, Nuclear Magnetic Resonance Spectroscopic

    Similar 510(k) Clearances

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

    OASIS MRI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MR SPECTROSCOPY PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAGE 7

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

    Other Clearances by Hitachi Medical Systems America, Inc.

    K Number Device Name
    K163528 HITACHI Supria Whole-body X-ray CT System Phase 3
    K162079 TRILLIUM Oval Head Coil 32
    K161748 SUPRIA w/guideShot Option
    K160152 Trillium Oval V 5.1 MRI System
    K153547 ECHELON Oval V 5.1 MRI System
    K150595 SCENARIA Phase 3 Whole-body X-ray CT System
    K150565 Supria Whole-body X-ray CT System
    K151015 ECHELON Oval V 5.0 MRI System
    K143537 Sirius Starmobile tiara
    K142734 TRILLIUM Oval MR System
    Search all 100 clearances from Hitachi Medical Systems America, Inc. →