FDA 510(k)

钻導引器；钻頭；脊椎與創傷導航

K 號：K240701 · 2024-05-23

決定日期2024-05-23

產品代碼OLO

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

Drill Guide; Drill Bit; Spine & Trauma 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 2024-05-23 under 510(k) number K240701. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Drill Guide; Drill Bit; Spine & Trauma Navigation?

Drill Guide; Drill Bit; Spine & Trauma Navigation is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Brainlab AG. The 510(k) number is K240701.

When did Drill Guide; Drill Bit; Spine & Trauma Navigation receive FDA 510(k) clearance?

Drill Guide; Drill Bit; Spine & Trauma Navigation received FDA 510(k) clearance on 2024-05-23, under 510(k) number K240701.

Who is the listed applicant for Drill Guide; Drill Bit; Spine & Trauma 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 Drill Guide; Drill Bit; Spine & Trauma Navigation?

The FDA product code for Drill Guide; Drill Bit; Spine & Trauma Navigation is OLO.

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 PAD K243142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 RT K243633Brainlab 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：OLO）

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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