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FDA 510(k)

DeepXray Spina

K号: K253192 · 2026-06-10

决定日期2026-06-10
产品代码SAO
咨询委员会RA
决定实质等同

器械摘要

DeepXray Spina is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Intelligence Manifolds, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K253192. The device is classified under product code SAO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DeepXray Spina?

DeepXray Spina is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Alpha Intelligence Manifolds, Inc.. The 510(k) number is K253192.

When did DeepXray Spina receive FDA 510(k) clearance?

DeepXray Spina received FDA 510(k) clearance on 2026-06-10, under 510(k) number K253192.

Who is the listed applicant for DeepXray Spina?

The FDA 510(k) record lists Alpha Intelligence Manifolds, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepXray Spina?

The FDA product code for DeepXray Spina is SAO.

相关临床试验

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列明Alpha Intelligence Manifolds, Inc.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:SAO)

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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