FDA applicant
Agfa Healthcare N.V.
FDA records 35 decisions for Agfa Healthcare N.V. (Greenville, SC) from 2007 to 2025: 35 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 64 predicates, 32 of them its own earlier devices. 28 recalls are linked to its devices.
FDA’s records also spell it “Agfa Healthcare Corporation”, “Agfa Healthcare Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Agfa Healthcare N.V.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
3in 2024
Class I Class II/III not classified
Planning a device like Agfa Healthcare N.V.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Agfa”
FDA records each applicant name separately; these may or may not be the same firm.