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

    MODIFICATION TO ARTOSCAN M

    K Number: K010057 · Decision Feb 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    20
    Review Days
    25

    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
    MODIFICATION TO ARTOSCAN M
    K Number
    K010057
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosound Esaote, Inc.
    Date Received
    January 8, 2001
    Decision Date
    February 2, 2001
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

    Similar 510(k) Clearances

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

    uMR Astra

    FDA 510(k)
    FDA Class 2 ·Radiology

    APERTO Lucent MRI System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    S-scan Open (100001800)

    FDA 510(k)
    FDA Class 2 ·Radiology

    nordicAudio (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Embrace Neonatal MRI System

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

    Other Clearances by Biosound Esaote, Inc.

    K Number Device Name
    K023255 TECHNOS MP, MODEL AU6
    K014168 AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
    K020164 E-SCAN XQ
    K012728 E-SCAN MRI SYSTEM
    K010405 7230 ULTRASOUND IMAGING SYSTEM WITH TEI
    K001894 MODIFICATION TO E-SCAN
    K000931 AU5 ULTRASOUND IMAGING SYSTEM
    K000681 AU5, AU6
    K994369 7250 (MEGAS)
    K990968 E-SCAN
    Search all 20 clearances from Biosound Esaote, Inc. →