K190330 is an FDA 510(k) clearance for the DRX-Evolution/Plus with Dual Energy. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on November 4, 2019, 263 days after receiving the submission on February 14, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K190330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2019 |
| Decision Date | November 04, 2019 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |