Nano-X AI Ltd.

Nano-X AI Ltd. specializes in medical imaging and diagnostic devices. Their portfolio includes systems for fluoroscopy (HealthFLD), contrast-enhanced imaging (HealthCCSng), ventilation control (HealthVCF), pneumothorax detection (HealthPNX+), and ostomy management (HealthOST). These devices are developed to support real-time imaging, respiratory monitoring, and patient assessment in radiology, critical care, and surgical environments.

Nano-X AI Ltd. is based in Israel. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Nano-X AI Ltd.’s devices are listed in the EUDAMED database under the EU Medical Device Regulations, as well as in the FDA’s 510(k) clearance registry. These registries track devices that have undergone the necessary regulatory processes for market authorization in the European Union and the United States, respectively.

Nano-X AI Ltd.’s devices are classified under the EU Medical Device Regulations as Class II, Class IIa, and Class IIb. This classification is based on the risk associated with the device’s intended use, with higher classes (e.g., Class IIb) indicating greater risk and stricter regulatory requirements. The classification determines the level of scrutiny and documentation required for market authorization.