K180589 is an FDA 510(k) clearance for the DR 800 with MUSICA Dynamic. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Agfa Healthcare N.V. (Mortsel, BE). The FDA issued a Cleared decision on April 5, 2018, 30 days after receiving the submission on March 6, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K180589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2018 |
| Decision Date | April 05, 2018 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |