雜交實境脊椎導航
K 號：K242569 · 2025-05-16
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器材摘要
Mixed Reality Spine Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K242569. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Mixed Reality Spine Navigation?
Mixed Reality Spine Navigation is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Brainlab AG. The 510(k) number is K242569.
When did Mixed Reality Spine Navigation receive FDA 510(k) clearance?
Mixed Reality Spine Navigation received FDA 510(k) clearance on 2025-05-16, under 510(k) number K242569.
Who is the listed applicant for Mixed Reality Spine Navigation?
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 Mixed Reality Spine Navigation?
The FDA product code for Mixed Reality Spine Navigation is SBF.
相關臨床試驗
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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)
相關器械（代碼：SBF）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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