K183275 is an FDA 510(k) clearance for the DR 800 with Tomosynthesis. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Agfa N.V. (Mortsel, BE). The FDA issued a Cleared decision on February 1, 2019, 70 days after receiving the submission on November 23, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K183275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2018 |
| Decision Date | February 01, 2019 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZF - System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |