The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dx-d Imaging Package (dr 10s), Dx-d Imaging Package (dr 14s), Dx-d Imaging Package (dr 14s).
| Device ID | K161368 |
| 510k Number | K161368 |
| Device Name: | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Agfa HealthCare N.V. Septestraat 27 Mortsel, BE B-2640 |
| Contact | Koen Vervoort |
| 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 | 2016-05-17 |
| Decision Date | 2016-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904222225 | K161368 | 000 |
| 05414904222218 | K161368 | 000 |
| 05414904222201 | K161368 | 000 |