K203782 is an FDA 510(k) clearance for the Nanox Cart X-ray System. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Nano-X Imaging , Ltd. (Neve Ilan, IL). The FDA issued a Cleared decision on April 1, 2021, 94 days after receiving the submission on December 28, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K203782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2020 |
| Decision Date | April 01, 2021 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| 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 |