K250850 is an FDA 510(k) clearance for the Nanox.ARC X. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Nano-X Imaging , Ltd. (Petah Tikva, IL). The FDA issued a Cleared decision on April 16, 2025, 27 days after receiving the submission on March 20, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K250850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2025 |
| Decision Date | April 16, 2025 |
| Days to Decision | 27 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 |