Data / Medical devices / Belgium / Agfa Healthcare N.V.
Agfa Healthcare N.V.: FDA-registered device maker in MORTSEL Antwerpen, Belgium, 14 510(k) clearances
Agfa Healthcare N.V. is registered with the FDA (registration 9616389) in MORTSEL Antwerpen, Belgium. It lists 2 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 3, 2017. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616389
- FEI number
- 3009471886
- Address
- Septestraat 27, MORTSEL Antwerpen, Belgium, B 2640
- Owner or operator
- AGFA HEALTHCARE N.V. (9011611)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 19, 2007
- Registered through
- 2026
- Brand names listed
- Enterprise Imaging, Enterprise Imaging Desktops, Enterprise Imaging XERO Viewer, Enterprise Imaging XERO Viewer 3D, Enterprise Imaging XERO Viewer 8.1, IMPAX, IMPAX Quality Control Workstation, IMPAX Clinical Workstation and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 2017 | K170434 | Enterprise Imaging XERO Viewer 8.1 | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| June 22, 2016 | K161061 | IMPAX Volume Viewing 4.0 | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| June 1, 2015 | K143397 | ICIS View | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| January 6, 2015 | K142316 | IMPAX Agility | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| March 7, 2014 | K133135 | IMPAX VOLUME VIEWING 3.0 | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 5, 2011 | K111945 | IMPAX NEXT GENERATION | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| June 24, 2011 | K111638 | IMPAX VOLUME VIEWING | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| July 28, 2008 | K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | LLZ | Substantially Equivalent | Agfa Healthcare Corporation | accessdata.fda.gov |
| January 17, 2008 | K080013 | REGISTRATION AND FUSION | LLZ | Substantially Equivalent | Agfa Healthcare Corporation | accessdata.fda.gov |
| July 30, 2007 | K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | LLZ | Substantially Equivalent | Agfa Healthcare Corp. | accessdata.fda.gov |
| April 21, 2005 | K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | LLZ | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| May 26, 2004 | K040555 | IMPAX CLIENT EMBRACE | LLZ | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| May 12, 2004 | K040344 | IMPAX OT3000 ORTHOPEDIC WORKSTATION | LLZ | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| September 12, 2002 | K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO | LLZ | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 6, 2024 | 95411 | Class II | Ongoing | Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data. Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3 | Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagn | accessdata.fda.gov |
| December 5, 2022 | 91357 | Class II | Ongoing | Agfa HealthCare Enterprise Imaging XERO Viewer | There is a software defect that can cause issues with images. | accessdata.fda.gov |
| December 4, 2018 | 81780 | Class II | Terminated | DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiol | After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position. | accessdata.fda.gov |
| August 3, 2018 | 80998 | Class II | Terminated | Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, dis | Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top. | accessdata.fda.gov |
Compare with other makers
Updated October 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.