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FDA 510(k)

BraiN20® (BraiN20)

K 號：K253301 · 2026-06-27

申請人Time IS Brain, S.L.
決定日期2026-06-27
產品代碼GWF
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

BraiN20® (BraiN20) is the device name listed in this FDA 510(k) record. The listed applicant is Time IS Brain, S.L.. It received FDA 510(k) clearance on 2026-06-27 under 510(k) number K253301. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BraiN20® (BraiN20)?

BraiN20® (BraiN20) is a medical device that received FDA 510(k) clearance on 2026-06-27. The listed applicant is Time IS Brain, S.L.. The 510(k) number is K253301.

When did BraiN20® (BraiN20) receive FDA 510(k) clearance?

BraiN20® (BraiN20) received FDA 510(k) clearance on 2026-06-27, under 510(k) number K253301.

Who is the listed applicant for BraiN20® (BraiN20)?

The FDA 510(k) record lists Time IS Brain, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BraiN20® (BraiN20)?

The FDA product code for BraiN20® (BraiN20) is GWF.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：GWF）

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。

K263010ISIS頭箱，ISIS神經刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS Xpressinomed Medizintechnik GmbHK252842SafeOp 3：神經資訊系統Alphatec Spine, Inc.K243982尼可萊特EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345德菲刺激器Quantalx NeuroscienceK234092SafeOp 3：神經資訊系統Alphatec Spine, Inc.

官方來源

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