FDA 510(k)

神經對齊軟體

K 號：K231897 · 2025-10-21

決定日期2025-10-21

產品代碼HAW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

NeuroAlign software is the device name listed in this FDA 510(k) record. The listed applicant is Medivis, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K231897. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuroAlign software?

NeuroAlign software is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Medivis, Inc.. The 510(k) number is K231897.

When did NeuroAlign software receive FDA 510(k) clearance?

NeuroAlign software received FDA 510(k) clearance on 2025-10-21, under 510(k) number K231897.

Who is the listed applicant for NeuroAlign software?

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

What is the FDA product code for NeuroAlign software?

The FDA product code for NeuroAlign software is HAW.

其他以 Medivis, Inc. 為申請人之記錄

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K233725脊椎導航系統 K190764外科AR

相關器械（代碼：HAW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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