The following data is part of a premarket notification filed by Agfa N.v. with the FDA for Dx-d Imaging Package With Xd Detectors.
| Device ID | K211790 |
| 510k Number | K211790 |
| Device Name: | DX-D Imaging Package With XD Detectors |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Agfa N.V. Septestraat 27 Mortsel, BE B-2640 |
| Contact | Wim Govaerts |
| Correspondent | Shaeann Cavanagh Agfa US Corp. 10 South Academy Street Greenville, SC 29601 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2021-07-30 |