BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

    K Number: K193006 · Decision Aug 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    18
    Review Days
    286

    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
    MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
    K Number
    K193006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5802
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tonica Elektronik A/S
    Date Received
    October 28, 2019
    Decision Date
    August 9, 2020
    Product Code
    QCI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

    Similar 510(k) Clearances

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

    MeRT System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ultimate rTMS for OCD (M-series)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BTL-99-OC

    FDA 510(k)
    FDA Class 2 ·Neurology

    CloudTMS Edge for OCD

    FDA 510(k)
    FDA Class 2 ·Neurology

    OCD MT Cap (85-00397-000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CloudTMS for OCD

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

    Other Clearances by Tonica Elektronik A/S

    K Number Device Name
    K260189 MagVenture Accelerated TMS (aTMS) Therapy System
    K251125 MagVenture TMS Therapy System
    K251119 MagVenture TMS Therapy System
    K252032 T65 (9016E061-)
    K230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
    K221544 MagVenture TMS Atlas Neuro Navigation System
    K173620 Mag Vita TMS Therapy System w/Theta Burst Stimulation
    K172667 MagVita TMS Therapy w/MagPro R20
    K171967 MagVita TMS Therapy System
    K171481 MagVita TMS Therapy System
    Search all 18 clearances from Tonica Elektronik A/S →