K210982 is an FDA 510(k) clearance for the AMX Navigate. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on April 28, 2021, 27 days after receiving the submission on April 1, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K210982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2021 |
| Decision Date | April 28, 2021 |
| Days to Decision | 27 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 |