K221803 is an FDA 510(k) clearance for the PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Sedecal., Sa. (Algete, ES). The FDA issued a Cleared decision on July 18, 2022, 26 days after receiving the submission on June 22, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K221803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2022 |
| Decision Date | July 18, 2022 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |