AGFA N.V.

FDA Device Registration & Listing · Mortsel Antwerpen, BE · Registration 3001556265

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001556265
FEI Number
3001556265
Entity Name
AGFA N.V.
City/State/Country
Mortsel Antwerpen, BE
Establishment Address
Septestraat 27, Mortsel Antwerpen B-2640, BE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Agfa N.V. (Owner Number: 10058267)
Owner / Operator Contact Address
Septestraat 27, Mortsel, BE-NOTA B-2640, BE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K172784
PMA Number
N/A

All Registered 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 NX 3 CR MM3 Extremities Set Drystar DT2 Mammo LS Ortho CP-GU M Drystar DT2B CP-BU M DR 100s NX 3 CR HD5 AEC Detector CR MD4R General SR Set DX-D 45C CR HD5 FLFS Detector NX 3 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 DX-D Imaging Package DR 14s DR 10s NX 3 Pixium 4343 RGE DR 400 FLFS NX 3 DR 400 Pixium 4343 RCE CR 10-X CR Reader CR MD1 General Set NX 3 CR MM3 Extremities Set CR MD4 General Set CR MD4.1 FLFS Set CR 85-X NX 3 DR 600 Pixium 4343 RCE Pixium 4343 RGE DR 600 FLFS Overlay NX 3 Radiology Diagnostic Kit 4343 C Radiology Diagnostic Kit 4343 R/F Radiology Diagnostic Kit 4343 G Drystar 5503 DR Retrofit NX 3 DX-D Retrofit DX-D Imaging Package IMPAX SE OrthoGon DX-D 100 FLFS DX-D 100+ DX-D 100 DX-D Imaging Package DX-D 60G DX-D 45C NX 3 DX-D 40C DX-D 40G DX-D 45G DX-D 60C Pixium FL4343 NX 4 DR 800 NX 3 DR 800 FLFS Overlay Wallstand WS-Manual-001 Wallstand WS-Manual-T-001 DR Retrofit XD 17 XD 10 XD 14 XD 10+ DX-D Imaging Package XD 14+ NX 3 XD 17+ XF+ 17 XF+ 10 XF+ 14 VALORY NX 3 NX 3 DX-D Imaging Package DR 10e DR 17e DR 14e

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LMC Camera, Multi Format, Radiological Radiology Class 2 892.2040 2018-08-31
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2018-08-31
IXJ Grid, Radiographic Radiology Class 1 892.1910 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
IWZ Film, Radiographic Radiology Class 1 892.1840 2018-08-31
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-08-12
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
OIP Radiology-Diagnostic Kit Radiology Class 2 892.1680 2018-08-31
LMC Camera, Multi Format, Radiological Radiology Class 2 892.2040 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-08-31
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2018-08-31
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31
IZF System, X-Ray, Tomographic Radiology Class 2 892.1740 2019-02-01
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2019-02-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-08-04
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-11-23
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2018-08-31

Official Correspondent

Koen Vervoort

US Agent Details

ShaeAnn Cavanagh Business: Agfa US Corp Email: shaeann.cavanagh@agfa.com Phone: (864) 3135016

Related Public Records

Same Entity

Agfa N.V.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9613152 AGFA-GEVAERT HEALTHCARE GMBH PEISSENBERG Bavaria, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201670 Siemens Medical Solutions USA, Inc. YSIO X.pree 2020-10-21
K123106 Samsung Electronics Co., Ltd. DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A 2013-06-20
K203340 Siemens Medical Solutions USA, Inc. MULTIX Impact C 2021-01-06
K230241 Sg Healthcare Co, Ltd. Jumong General 2023-02-23
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2009 GE Medical Systems, LLC 2
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015 Siemens Medical Solutions USA, Inc 2
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009 GE Medical Systems, LLC 2
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
Z-0003-2015 Siemens Medical Solutions USA, Inc 2
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Z-0004-2015 Siemens Medical Solutions USA, Inc 2
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001556265. Last updated year: 2026. Please use registration number 3001556265 when referencing this establishment in official correspondence.
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