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FDA 510(k)

頭部對位系統，配備頭部對位軟體頭部LITT；Cirq頭部對位軟體頭部活組織切片；Cirq頭部對位軟體頭部sEEG；VarioGuide頭部對位軟體；Cirq頭部對位軟體頭部LITT

K 號：K243698 · 2025-01-28

申請人Brainlab AG
決定日期2025-01-28
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

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-01-28 under 510(k) number K243698. 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 Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT?

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT is a medical device that received FDA 510(k) clearance on 2025-01-28. The listed applicant is Brainlab AG. The 510(k) number is K243698.

When did Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT receive FDA 510(k) clearance?

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT received FDA 510(k) clearance on 2025-01-28, under 510(k) number K243698.

Who is the listed applicant for Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT?

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

What is the FDA product code for Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT?

The FDA product code for Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT is HAW.

相關臨床試驗

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。

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

其他以 Brainlab AG 為申請人之記錄

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。

K252476視覺器（5.4）；元素視覺器；混合現實視覺器；智慧佈局；元素視覺器智慧佈局K252562脊椎與創傷導航儀器K243432血管導航 PAD 2.0；血管導航軟體 Vascular PADK243142頭部4Pi固定器K250440RT 元素 (4.5)；（元素）多個腦部轉移SRS；（元素）頭部SRS；（元素）脊柱SRS；（元素）帶有錐體的頭部SRS；（元素）RT計劃平台；（元素）劑量複查；（元素）重治療複查；元素分割 [頭部、基底核、頭頸、骨盆、脊柱、胸椎與脊柱、頭外] RT；元素 AI 肿瘤分割 RT；元素智能刷 [血管、脊柱] RT；元素物件管理 RTK243633Brainlab Elements (7.0)；Brainlab Elements 圖像融合 (5.0)；Brainlab Elements 圖像融合 Angio (1.0)；Brainlab Elements 線條輪廓 (5.0)；Brainlab Elements 纤維追蹤 (3.0)；Brainlab Elements BOLD MRI 地圖 (1.0)

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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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