K201488 is an FDA 510(k) clearance for the Rover. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Micro-X , Ltd. (Tonsley (Clovelly Park), AU). The FDA issued a Cleared decision on July 17, 2020, 43 days after receiving the submission on June 4, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K201488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2020 |
| Decision Date | July 17, 2020 |
| Days to Decision | 43 days |
| Submission Type | Abbreviated |
| 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 |