FDA 510(k)

VUNO 医用胸部X光分诊/VUNO 医用CXR链接分诊

K号: K241439 · 2024-11-15

决定日期2024-11-15

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is the device name listed in this FDA 510(k) record. The listed applicant is Vuno, Inc.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K241439. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage?

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Vuno, Inc.. The 510(k) number is K241439.

When did VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage receive FDA 510(k) clearance?

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage received FDA 510(k) clearance on 2024-11-15, under 510(k) number K241439.

Who is the listed applicant for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage?

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

What is the FDA product code for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage?

The FDA product code for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is QFM.

列明Vuno, 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。

K231398VUNO 医疗设备监管文本

官方来源

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