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 | K122736 |
| 510k Number | K122736 |
| Device Name: | DX-D IMAGING PACKAGE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE N.V. PO BOX 1927 Brevard, NC 28712 |
| Contact | David Ledwig |
| Correspondent | David Ledwig AGFA HEALTHCARE N.V. PO BOX 1927 Brevard, NC 28712 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-19 |
| Decision Date | 2013-03-11 |
| Summary: | summary |