Agfa N.V.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2738-2024Class IIDR 800. Digital Radiography X-ray System.July 29, 2024
Z-1462-2024Class IIAgfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting ofFebruary 23, 2024
Z-2202-2020Class IIAGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product UApril 6, 2020
Z-1502-2020Class IIAGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - ProduFebruary 10, 2020
Z-2056-2019Class IIAGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 8June 27, 2019
Z-1034-2019Class IIIPET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. PJanuary 25, 2019
Z-3245-2018Class IIDX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imagiAugust 15, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K213469VALORYNovember 18, 2021
K212145DR 800 with DSA, DR 800August 31, 2021
K211790DX-D Imaging Package with XD DetectorsJuly 30, 2021
K193262DR 600 with TomosynthesisMarch 9, 2020
K191884DR 100sAugust 9, 2019
K183275DR 800 with TomosynthesisFebruary 1, 2019