BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    AGFA N.V.

    Reg #: 3001556265 · FEI: 3001556265 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    103
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    AGFA N.V.
    Registration Number
    3001556265
    FEI Number
    3001556265
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Septestraat 27
    City
    Mortsel Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K032635

    Owner / Operator

    Firm Name
    Agfa N.V.
    Operator Number
    10058267
    Address
    Septestraat 27
    City
    Mortsel
    State
    BE-NOTA
    Postal Code
    B-2640
    Country
    BE
    Correspondent
    Koen Vervoort

    US Agent

    Business Name
    Agfa US Corp
    Contact Name
    ShaeAnn Cavanagh
    Address
    580 Gotham Parkway
    City
    Carlstadt
    State
    NJ
    ZIP
    07072
    Country
    US
    Email
    [email protected]
    Phone
    864 3135016

    Products

    Device Name Product Code
    Camera, Multi Format, Radiological LMC
    System, X-Ray, Stationary KPR
    Grid, Radiographic IXJ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Film, Radiographic IWZ
    System, X-Ray, Mobile IZL
    Radiology-Diagnostic Kit OIP
    System, Image Processing, Radiological LLZ
    System, X-Ray, Tomographic IZF
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Full Field Digital, System, X-Ray, Mammographic MUE
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    Crystal Imager Drystar 5302 DX-D FLFS Horizontal Overlay DX-D 600 Pixium 4343 RGE Pixium 4343 RCE CR Antiscatter grid CR Advanced Reader CR Multi-Format Reader CR HD5S General Detector CR 15-X CR 12-X CR MD1 General Set DX-D 400 CR 30-X CR MD4T FLFS Set NX 3 CR MD4T General Set CR MD4 General Set CR MD4 General Set SR CR 25 Digitizer CR MD4.1 FLFS Set CR MM3 Extremities Set Drystar DT2 Mammo LS Ortho CP-GU M Drystar DT2B CP-BU M DR 100s CR HD5 AEC Detector CR MD4R General SR Set DX-D 45C CR HD5 FLFS Detector CR HD5 General Detector DR 17e CR MD4R FLFS Set DX-D 40C DX-D 60C DR 10e DR 10s DR 14e CR HD5 General SR Detector CR MD4R General Set DX-D Imaging Package DR 14s DR 400 FLFS DR 400 CR 10-X CR Reader CR 85-X DR 600 DR 600 FLFS Overlay Radiology Diagnostic Kit 4343 C Radiology Diagnostic Kit 4343 R/F Radiology Diagnostic Kit 4343 G Drystar 5503 DR Retrofit DX-D Retrofit IMPAX SE OrthoGon DX-D 100 FLFS DX-D 100+ DX-D 100 DX-D 60G DX-D 40G DX-D 45G Pixium FL4343 NX 4 DR 800 DR 800 FLFS Overlay Wallstand WS-Manual-001 Wallstand WS-Manual-T-001 XD 17 XD 10 XD 14 XD 10+ XD 14+ XD 17+ XF+ 17 XF+ 10 XF+ 14 VALORY DX-D FLFS Stand DX-D 300 DX-M CR HD5 Extremities Detector Digital Subtraction Angiography (DSA) EasyLift WS-Manual-001 WS-Manual-T-001 CR MD4 General Set HR DX-G CR HD5 FLFS Cassette CR HD5 General Cassette XRDI Varian 4336R Varian 4334R Drystar AXYS Crystal-M Imager Drystar AXYS XL Pixium RAD 4343 MUSICA Engine Auto QC2 Mammography

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device