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FDA 510(k)

Nanox.ARC X

K-Number: K250850 · 2025-04-16

ApplicantNano-X Imaging , Ltd.
Decision Date2025-04-16
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nanox.ARC X is a medical device manufactured by Nano-X Imaging , Ltd.. It received FDA 510(k) clearance on 2025-04-16 under approval number K250850. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nanox.ARC X?

Nanox.ARC X is a medical device that received FDA 510(k) clearance on 2025-04-16. It is manufactured by Nano-X Imaging , Ltd.. The 510(k) number is K250850.

When was Nanox.ARC X approved by the FDA?

Nanox.ARC X received FDA 510(k) clearance on 2025-04-16, under approval number K250850.

What company makes Nanox.ARC X?

Nanox.ARC X is manufactured by Nano-X Imaging , Ltd..

What is the FDA product code for Nanox.ARC X?

The FDA product code for Nanox.ARC X is IZF.

Other Devices by Nano-X Imaging , Ltd.

K203782Nanox Cart X-ray System K222934Nanox.ARC K242395Nanox.ARC K252649TAP2D

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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