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FDA 510(k)

認知功能神經影像學(cfNI)軟體(1.0.0)

K 號:K253015 · 2026-06-12

決定日期2026-06-12
產品代碼OLU
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

Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is VoxNeuro, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253015. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is VoxNeuro, Inc.. The 510(k) number is K253015.

When did Cognitive Function Neuroimaging (cfNI) Software (1.0.0) receive FDA 510(k) clearance?

Cognitive Function Neuroimaging (cfNI) Software (1.0.0) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253015.

Who is the listed applicant for Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

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

What is the FDA product code for Cognitive Function Neuroimaging (cfNI) Software (1.0.0)?

The FDA product code for Cognitive Function Neuroimaging (cfNI) Software (1.0.0) is OLU.

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相關器械(代碼:OLU)

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。

官方來源

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