Agfa N.V.
Medical device manufacturer in Mortsel, Belg.
6510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213469 | ValoryMQB · Traditional | 11/18/2021SE |
| K212145 | DR 800 with DSA, DR 800JAA · Traditional | 08/31/2021SE |
| K211790 | DX-D Imaging Package with XD DetectorsMQB · Traditional | 07/30/2021SE |
| K193262 | DR 600 with TomosynthesisIZF · Traditional | 03/09/2020SE |
| K191884 | DR 100sIZL · Traditional | 08/09/2019SE |
| K183275 | DR 800 with TomosynthesisIZF · Traditional | 02/01/2019SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2738-2024 Class II | DR 800. Digital Radiography X-ray System.Potential for the front lever chain of the DR 800 table to fail. | 07/29/2024Open, Classified |
| Z-1462-2024 Class II | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality…Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube… | 02/23/2024Open, Classified |
| Z-2202-2020 Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200…Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the… | 04/06/2020Terminated |
| Z-1502-2020 Class II | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray…Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. | 02/10/2020Terminated |
| Z-2056-2019 Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The…The exposed area of fluo exams possibly does not match the active area of the detector within specified… | 06/27/2019Terminated |
| Z-1034-2019 Class III | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85…Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the… | 01/25/2019Terminated |
| Z-3245-2018 Class II | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography…A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break.… | 08/15/2018Terminated |