The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dx-d Imaging Package.
| Device ID | K172784 |
| 510k Number | K172784 |
| Device Name: | DX-D Imaging Package |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Agfa HealthCare N.V. Septestraat 27 Mortsel, BE B-2640 |
| Contact | Wim Govaerts |
| Correspondent | Shaeann Cavanagh Agfa Healthcare 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 | 2017-09-15 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904233313 | K172784 | 000 |
| 05414904233306 | K172784 | 000 |
| 05414904233290 | K172784 | 000 |
| 05414904233283 | K172784 | 000 |
| 05414904252529 | K172784 | 000 |