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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 the device name listed in this FDA 510(k) record. The listed applicant is Nano-X Imaging , Ltd.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) 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. The listed applicant is Nano-X Imaging , Ltd.. The 510(k) number is K250850.

When did Nanox.ARC X receive FDA 510(k) clearance?

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

Who is the listed applicant for Nanox.ARC X?

The FDA 510(k) record lists Nano-X Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Nano-X Imaging , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252649TAP2DK242395Nanox.ARCK222934Nanox.ARCK203782Nanox Cart X-ray System

Related Devices (Code: IZF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbHK213081CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A

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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