BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASPEN IMAGING HEALTHCARE, INC

    Reg #: 3012624817 · FEI: 3012624817 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    10
    Establishment Types
    4
    Classifications
    9

    Registration Details

    Registration Name
    ASPEN IMAGING HEALTHCARE, INC
    Registration Number
    3012624817
    FEI Number
    3012624817
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    801 north Jupiter rd, 200
    City
    Plano
    State
    TX
    ZIP
    75074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241346

    Owner / Operator

    Firm Name
    ASPEN IMAGING HEALTHCARE, INC
    Operator Number
    10051160
    Address
    801 Jupiter Rd, Suite 200, 200
    City
    Plano
    State
    TX
    Postal Code
    75074
    Country
    US

    Products

    Device Name Product Code
    Tube Mount, X-Ray, Diagnostic IYB
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Digital Image Communications, Radiological LMD
    System, X-Ray, Angiographic IZI
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Stationary KPR
    System, X-Ray, Mobile IZL

    Proprietary Names

    ASPENXDR IODR1417-GF IODR1417 IODR1717 AsepenVue ASPENVUE FLUSION 9001 - Fluoroscopic C-Arm Mobile X- Ray System AspenFDR; AspenUDR; AspenXDR APX-24 Portable X-ray System EUROPA85, EUROPA85L, EUROPA90, EUROPA90L- Portable X-Ray System

    Establishment Types

    Repack or Relabel Medical Device Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device