Agfa N.V.
FDA Regulatory Profile
Agfa N.V. appears in FDA public data with 7 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2738-2024, Class II) was initiated on July 29, 2024. Its most recent 510(k) clearance was granted on November 18, 2021.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2738-2024 | Class II | DR 800. Digital Radiography X-ray System. | July 29, 2024 |
| Z-1462-2024 | Class II | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of | February 23, 2024 |
| Z-2202-2020 | Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product U | April 6, 2020 |
| Z-1502-2020 | Class II | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Produ | February 10, 2020 |
| Z-2056-2019 | Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 8 | June 27, 2019 |
| Z-1034-2019 | Class III | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. P | January 25, 2019 |
| Z-3245-2018 | Class II | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imagi | August 15, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213469 | VALORY | November 18, 2021 |
| K212145 | DR 800 with DSA, DR 800 | August 31, 2021 |
| K211790 | DX-D Imaging Package with XD Detectors | July 30, 2021 |
| K193262 | DR 600 with Tomosynthesis | March 9, 2020 |
| K191884 | DR 100s | August 9, 2019 |
| K183275 | DR 800 with Tomosynthesis | February 1, 2019 |