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FDA 510(k)

Nanox Cart X-ray System

K-Number: K203782 · 2021-04-01

Decision Date2021-04-01
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nanox Cart X-ray System is a medical device manufactured by Nano-X Imaging , Ltd.. It received FDA 510(k) clearance on 2021-04-01 under approval number K203782. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nanox Cart X-ray System?

Nanox Cart X-ray System is a medical device that received FDA 510(k) clearance on 2021-04-01. It is manufactured by Nano-X Imaging , Ltd.. The 510(k) number is K203782.

When was Nanox Cart X-ray System approved by the FDA?

Nanox Cart X-ray System received FDA 510(k) clearance on 2021-04-01, under approval number K203782.

What company makes Nanox Cart X-ray System?

Nanox Cart X-ray System is manufactured by Nano-X Imaging , Ltd..

What is the FDA product code for Nanox Cart X-ray System?

The FDA product code for Nanox Cart X-ray System is IZL.

Other Devices by Nano-X Imaging , Ltd.

Related Devices (Code: IZL)

Official Source

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