BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accogent Pausch

    Reg #: 2243057 · FEI: 2243057 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    Accogent Pausch
    Registration Number
    2243057
    FEI Number
    2243057
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    808 Shrewsbury Ave
    City
    Tinton Falls
    State
    NJ
    ZIP
    07724
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110856

    Owner / Operator

    Firm Name
    PAUSCH LLC
    Operator Number
    2243057
    Address
    808 SHREWSBURY AVENUE, --
    City
    Eatontown
    State
    NJ
    Postal Code
    07724
    Country
    US
    Correspondent
    JUSTIN - TICE

    Products

    Device Name Product Code
    Collimator, Manual, Radiographic IZX
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Tube Mount, X-Ray, Diagnostic IYB
    Table, Radiographic, Non-Tilting, Powered IZZ
    System, X-Ray, Tomographic IZF
    System, X-Ray, Stationary KPR
    Table, Radiographic, Stationary Top IXQ
    Interventional Fluoroscopic X-Ray System OWB
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Table, Radiographic, Tilting IXR
    Table, Cystometric, Electric MMZ
    Table, Cystometric, Non-Electric And Accessories KQS

    Proprietary Names

    FS 100 FS 100 RH FS 100 LH Cirrus RS 3000 Legacy S MPRT Bucky ElevatorMax CombiMax LH CombiMax CombiMax RH MPRT S MPRT Paxis 250 Paxis 100 Auto RH Paxis 100 Auto Paxis 200 Paxis 100 Paxis 100 Auto LH Vision HDR Bladeview HDR HDR Vision Bladeview UT-2000 Legacy

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device