The following data is part of a premarket notification filed by Nano-x Imaging Ltd. with the FDA for Nanox Cart X-ray System.
| Device ID | K203782 |
| 510k Number | K203782 |
| Device Name: | Nanox Cart X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | Nano-x Imaging Ltd. Communications Center Building C, Entrance 1 Neve Ilan, IL 9085000 |
| Contact | Yuval Shapiro |
| Correspondent | Rafael Aguila Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-04-01 |