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FDA 510(k)

Nanox.ARC

K号: K242395 · 2024-12-04

决定日期2024-12-04
产品代码IZF
咨询委员会RA
决定实质等同

器械摘要

Nanox.ARC 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 2024-12-04 under 510(k) number K242395. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nanox.ARC?

Nanox.ARC is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Nano-X Imaging , Ltd.. The 510(k) number is K242395.

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

Nanox.ARC received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242395.

Who is the listed applicant for Nanox.ARC?

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?

The FDA product code for Nanox.ARC is IZF.

相关临床试验

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列明Nano-X Imaging , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

相关器械(代码:IZF)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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