Data / Medical devices / Canada / Agfa Healthcare Inc.
Agfa Healthcare Inc.: FDA-registered device maker in WATERLOO Ontario, Canada, 11 510(k) clearances
Agfa Healthcare Inc. is registered with the FDA (registration 9680497) in WATERLOO Ontario, Canada. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 3, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680497
- FEI number
- 3008794078
- Address
- 375 Hagey Boulevard, WATERLOO Ontario, Canada, N2L 6R5
- Owner or operator
- AGFA HEALTHCARE N.V. (9011611)
- Roles
- 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 8.1, IMPAX, IMPAX Quality Control Workstation, IMPAX Clinical Workstation, IMPAX Diagnostic Workstation and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | 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 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 |
| August 5, 2011 | K111945 | IMPAX NEXT GENERATION | 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 |
Compare with other makers
Updated July 3, 2017. 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.