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.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Agfa-Gevaert and its 3 subsidiaries with 69 510(k) clearances, 34 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated Oct 15, 2025: AGFA HealthCare Enterprise Imaging.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Agfa-Gevaert and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 15, 2025 | AGFA HealthCare Enterprise ImagingK252199 · LLZ | 510(k) clearances |
| 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 |
| Mar 9, 2020 | DR 600 with TomosynthesisK193262 · IZF | 510(k) clearances |
| Aug 9, 2019 | DR 100sK191884 · IZL | 510(k) clearances |
| Feb 1, 2019 | DR 800 with TomosynthesisK183275 · IZF | 510(k) clearances |
| Dec 4, 2018 | DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system usedClass II · After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane | Device recalls |
| Apr 5, 2018 | DR 800 with MUSICA DynamicK180589 · JAA | 510(k) clearances |
| Apr 5, 2018 | DR 800 with MUSICA DynamicK180589 · Radiology | AI-enabled devices |
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
