Nanox Cart X-ray System
by Nano-X Imaging, Ltd. 510(k)
Active
510(k) K203782
Overview
The Nanox Cart X-ray System is a mobile X-ray system designed for radiology applications. It is a Class II device that functions as an X-ray source for medical imaging purposes.
The device is manufactured by Nano-X Imaging Ltd. and has received FDA 510(k) clearance with the K number K203782. It is intended for use in healthcare settings and is supplied with various registration numbers and FEI numbers as specified in the regulatory documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203782 | Date1 Apr 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IZL
- FDA applicant
- Nano-X Imaging , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Nano-X Imaging, Ltd.
Questions
What is the Nanox Cart X-ray System used for?
The Nanox Cart X-ray System is a mobile X-ray system designed specifically for radiology applications in healthcare settings. It functions as an X-ray source for medical imaging purposes, allowing for flexible imaging capabilities within various clinical environments.
Is the Nanox Cart X-ray System cleared by regulatory authorities?
Yes, the Nanox Cart X-ray System has received FDA 510(k) clearance with the K number K203782. It is classified as a Class II device and has been determined to be substantially equivalent to predicate devices for mobile X-ray systems in radiology applications.
How is the Nanox Cart X-ray System supplied and what are its regulatory identifiers?
The device is supplied with various registration numbers and FEI numbers as specified in the regulatory documentation. These identifiers include multiple FEI numbers such as 3015223550, 3002808139, and others, along with corresponding registration numbers that track the device through regulatory processes.
What is the product code and classification of the Nanox Cart X-ray System?
The Nanox Cart X-ray System is classified under product code IZL and is designated as a Class II device. This classification indicates moderate-risk medical devices that require special controls to ensure their safety and effectiveness for their intended use in radiology applications.