FDA 510(k)

VUNO メディカル-チェスト X線診別/VUNO メディカル-CXR リンク診別

K番号: K241439 · 2024-11-15

決定日2024-11-15

製品コードQFM

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてVuno, Inc.を記載するその他の記録

K231398VUNO メディカル-ディープブレイン

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