K172784 is an FDA 510(k) clearance for the DX-D Imaging Package. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Agfa Healthcare N.V. (Mortsel, BE). The FDA issued a Cleared decision on October 13, 2017, 28 days after receiving the submission on September 15, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K172784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2017 |
| Decision Date | October 13, 2017 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB — Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |