FDA 510(k) Applications Submitted by Agfa N.V.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K211790 | 06/10/2021 | DX-D Imaging Package with XD Detectors | Agfa N.V. |
| K212145 | 07/09/2021 | DR 800 with DSA, DR 800 | Agfa N.V. |
| K191884 | 07/15/2019 | DR 100s | Agfa N.V. |
| K213469 | 10/28/2021 | VALORY | Agfa N.V. |
| K183275 | 11/23/2018 | DR 800 with Tomosynthesis | Agfa N.V. |
| K193262 | 11/26/2019 | DR 600 with Tomosynthesis | Agfa N.V. |
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