Company ยท BE
Agfa N.V.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2021. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2021 | K213469 | VALORY Agfa N.V., BE | MQB |
| Aug 31, 2021 | K212145 | DR 800 with DSA, DR 800 Agfa N.V., BE | JAA |
| Jul 30, 2021 | K211790 | DX-D Imaging Package with XD Detectors Agfa N.V., BE | MQB |
| Mar 9, 2020 | K193262 | DR 600 with Tomosynthesis Agfa N.V., BE | IZF |
| Aug 9, 2019 | K191884 | DR 100s Agfa N.V., BE | IZL |
| Feb 1, 2019 | K183275 | DR 800 with Tomosynthesis Agfa N.V., BE | IZF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2024 | Agfa N.V. DR 800. Digital Radiography X-ray System. Open, Classified |
JAA | K180589 K183275 |
| Apr 2, 2024 | Agfa N.V. Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generat Open, Classified |
IZL | K103597 |
| Apr 6, 2020 | Agfa N.V. 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 indicated for performing dynamic imaging examinations (fluoros Terminated |
JAA | K180589 |
| Feb 10, 2020 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. Th Terminated |
IZF | K183275 |
| Jun 27, 2019 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Product Usage:
The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) Terminated |
JAA | K180589 |
| Jan 25, 2019 | Agfa N.V. PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film
REF:
XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark im Terminated |
IWZ | None listed |
| Sep 25, 2018 | Agfa N.V. DX-D 600
Product Usage:
The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologist Terminated |
KPR | K112670 |