K222934 is an FDA 510(k) clearance for the Nanox.ARC. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Nano-X Imaging , Ltd. (Neve Ilan, IL). The FDA issued a Cleared decision on April 28, 2023, 214 days after receiving the submission on September 26, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K222934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | April 28, 2023 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZF — System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |