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

    H.I.STANDARD CALIBRE UPGRADE

    K Number: K911746 · Decision Aug 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    5
    Review Days
    120

    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
    H.I.STANDARD CALIBRE UPGRADE
    K Number
    K911746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Health Images, Inc.
    Date Received
    April 18, 1991
    Decision Date
    August 16, 1991
    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 Health Images, Inc.

    K Number Device Name
    K964778 HI-STAR MRI IMAGING SYSTEM
    K944724 HEALTH IMAGE INC. HI STAR
    K944228 HEALTH IMAGES, INC. HI-STANDARD
    K890092 HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE