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FDA 510(k)

a2z-统一分诊

K号: K252366 · 2025-11-24

决定日期2025-11-24
产品代码QAS
咨询委员会RA
决定实质等同

器械摘要

a2z-Unified-Triage is the device name listed in this FDA 510(k) record. The listed applicant is A2z Radiology Ai, Inc.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K252366. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the a2z-Unified-Triage?

a2z-Unified-Triage is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is A2z Radiology Ai, Inc.. The 510(k) number is K252366.

When did a2z-Unified-Triage receive FDA 510(k) clearance?

a2z-Unified-Triage received FDA 510(k) clearance on 2025-11-24, under 510(k) number K252366.

Who is the listed applicant for a2z-Unified-Triage?

FDA 510(k)记录中列出了A2z Radiology Ai, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for a2z-Unified-Triage?

The FDA product code for a2z-Unified-Triage is QAS.

相关临床试验

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。

列明A2z Radiology Ai, 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:QAS)

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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