Data / Medical devices / Belgium / Agfa N.V.
Agfa N.V.: FDA-registered device maker in Mortsel Antwerpen, Belgium, 31 510(k) clearances
Agfa N.V. is registered with the FDA (registration 3001556265) in Mortsel Antwerpen, Belgium. It lists 13 device types. The FDA files 31 510(k) clearances under its listings, the newest dated November 18, 2021. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001556265
- Address
- Septestraat 27, Mortsel Antwerpen, Belgium, B-2640
- Owner or operator
- Agfa N.V. (10058267)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 31, 2018
- Registered through
- 2026
- Brand names listed
- Auto QC2 Mammography, CP-BU M, CR 10-X, CR 12-X, CR 15-X, CR 25 Digitizer, CR 30-X, CR 85-X and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | LMC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Grid, Radiographic | IXJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Radiology-Diagnostic Kit | OIP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomographic | IZF | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 18, 2021 | K213469 | VALORY | MQB | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| August 31, 2021 | K212145 | DR 800 with DSA, DR 800 | JAA | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| July 30, 2021 | K211790 | DX-D Imaging Package with XD Detectors | MQB | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| March 9, 2020 | K193262 | DR 600 with Tomosynthesis | IZF | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| August 9, 2019 | K191884 | DR 100s | IZL | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| February 1, 2019 | K183275 | DR 800 with Tomosynthesis | IZF | Substantially Equivalent | Agfa N.V. | accessdata.fda.gov |
| April 5, 2018 | K180589 | DR 800 with MUSICA Dynamic | JAA | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| October 13, 2017 | K172784 | DX-D Imaging Package | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| September 22, 2016 | K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| December 11, 2015 | K152639 | DR 600 | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| October 16, 2014 | K142184 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| September 12, 2014 | K141602 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| June 6, 2014 | K141192 | DR 400 | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 29, 2013 | K131408 | CR 12-X DIGITIZER | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 16, 2012 | K121095 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| July 20, 2012 | K121948 | CR 10-X DIGITIZER | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| December 22, 2011 | K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | MUE | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| October 27, 2011 | K112670 | DX-D 600 | KPR | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| January 3, 2011 | K103597 | DX-D 100 | IZL | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| October 29, 2010 | K103050 | DX-D 300 | KPR | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| November 6, 2009 | K092669 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 11, 2009 | K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| May 18, 2009 | K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS | MQB | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| October 25, 2007 | K072680 | DRYSTAR AXYS, MODEL EYZ4E | LMC | Substantially Equivalent | Agfa Healthcare Corporation | accessdata.fda.gov |
| June 22, 2007 | K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | LLZ | Substantially Equivalent | Agfa Healthcare Corp. | accessdata.fda.gov |
| October 13, 2006 | K062742 | CR 85-X | MQB | Substantially Equivalent | Agfa Corporation | accessdata.fda.gov |
| September 1, 2006 | K062223 | AGFA MODEL CR30-X | MQB | Substantially Equivalent | Agfa Corporation | accessdata.fda.gov |
| July 22, 2004 | K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | MQB | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| September 24, 2003 | K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | LMC | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| October 22, 2002 | K023287 | DRYSTAR 5500 | LMC | Substantially Equivalent | Agfa Corp. | accessdata.fda.gov |
| November 2, 2001 | K012546 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM | KPR | Substantially Equivalent | Sedecal USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 29, 2024 | 95115 | Class II | Ongoing | DR 800. Digital Radiography X-ray System. | Potential for the front lever chain of the DR 800 table to fail. | accessdata.fda.gov |
| February 23, 2024 | 94143 | Class II | Ongoing | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray i | Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury | accessdata.fda.gov |
| April 6, 2020 | 85599 | Class II | Terminated | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid se | Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible | accessdata.fda.gov |
| February 10, 2020 | 85028 | Class II | Terminated | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not inte | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. | accessdata.fda.gov |
| June 27, 2019 | 83400 | Class II | Terminated | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an a | The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. | accessdata.fda.gov |
| January 25, 2019 | 82123 | Class III | Terminated | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the p | Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities | accessdata.fda.gov |
| August 15, 2018 | 81046 | Class II | Terminated | DX-D 600 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 radiologists to make, process an | A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Multi Format, Radiological
- All makers of Full Field Digital, System, X-Ray, Mammographic
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Mobile
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of System, X-Ray, Stationary
Updated August 27, 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.