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

    RTHawk, HeartVista Cardiac Package

    K Number: K153740 · Decision Jun 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    6
    Review Days
    185

    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
    RTHawk, HeartVista Cardiac Package
    K Number
    K153740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartvista, Inc.
    Date Received
    December 28, 2015
    Decision Date
    June 30, 2016
    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 Heartvista, Inc.

    K Number Device Name
    K212233 RTHawk, HeartVista Cardiac Package
    K183274 RTHawk, HeartVista Cardiac Package
    K170090 RTHawk, HeartVista Cardiac Package
    K142997 RTHawk, HeartVista Workstation with RTHawk
    K133848 RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK