Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in BelgiumLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Agfa-GevaertLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Agfa with 29 510(k) clearances and 18 device recalls. The most recent is a device recall dated Jul 29, 2024: DR 800. Digital Radiography X-ray System..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 29, 2024 | DR 800. Digital Radiography X-ray System.Class II · Potential for the front lever chain of the DR 800 table to fail. | Device recalls |
| Feb 23, 2024 | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digitalClass II · Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has po | Device recalls |
| Nov 18, 2021 | VALORYK213469 · MQB | 510(k) clearances |
| Aug 31, 2021 | DR 800 with DSA, DR 800K212145 · JAA | 510(k) clearances |
| Jul 30, 2021 | DX-D Imaging Package with XD DetectorsK211790 · MQB | 510(k) clearances |
| Apr 6, 2020 | 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 inClass II · Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute | Device recalls |
| Mar 9, 2020 | DR 600 with TomosynthesisK193262 · IZF | 510(k) clearances |
| Feb 10, 2020 | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthClass II · Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. | Device recalls |
| Aug 9, 2019 | DR 100sK191884 · IZL | 510(k) clearances |
| Jun 27, 2019 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dyClass II · The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. | Device recalls |
| Feb 1, 2019 | DR 800 with TomosynthesisK183275 · IZF | 510(k) clearances |
| Jan 25, 2019 | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneousClass III · Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes va | Device recalls |
| Aug 15, 2018 | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics andClass II · A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to | Device recalls |
| Nov 22, 2006 | DX-SIK063421 · MQB | 510(k) clearances |
| Oct 13, 2006 | CR 85-XK062742 · MQB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
