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

    Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

    K Number: K193147 · Decision Mar 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    28
    Review Days
    113

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    Basic Information

    Device Name
    Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
    K Number
    K193147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stereotaxis, Inc.
    Date Received
    November 13, 2019
    Decision Date
    March 5, 2020
    Product Code
    PJB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PJB Catheter Remote Control System

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    Other Clearances by Stereotaxis, Inc.

    K Number Device Name
    K253473 Synchrony
    K251792 Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
    K250590 MAGiC Sweep™ EP Mapping Catheter
    K192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
    K183027 Steerable catheter control system
    K150312 Vdrive system, Vdrive Duo, Vdrive with V-Sono
    K141530 VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
    K140804 VDRIVE WITH V-LOOP/ VDRIVE DUO
    K133396 VDRIVE WITH V-SONO
    K122659 VDRIVE W/V-SONO
    Search all 28 clearances from Stereotaxis, Inc. →