# K203782: Nanox Cart X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Nano-X Imaging, Ltd.
- Decided: Apr 1, 2021 after 94 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K802047 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021016: Amx-4 Plus Mobile X-Ray System, GE Medical Systems (2002) Summary page 4.

## Indications for use
The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed. Indication for Use — The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. Limitations for use — This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.

Source page: https://510kreport.com/device/K203782
Methodology: https://510kreport.com/methodology