FDA 510(k)

Visualase MRI導引激光消融系統（SW 3.4）

K 號：K211269 · 2022-01-07

決定日期2022-01-07

產品代碼ONO

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Visualase MRI-Guided Laser Ablation System (SW 3.4) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211269. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Visualase MRI-Guided Laser Ablation System (SW 3.4)?

Visualase MRI-Guided Laser Ablation System (SW 3.4) is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K211269.

When did Visualase MRI-Guided Laser Ablation System (SW 3.4) receive FDA 510(k) clearance?

Visualase MRI-Guided Laser Ablation System (SW 3.4) received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211269.

Who is the listed applicant for Visualase MRI-Guided Laser Ablation System (SW 3.4)?

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

What is the FDA product code for Visualase MRI-Guided Laser Ablation System (SW 3.4)?

The FDA product code for Visualase MRI-Guided Laser Ablation System (SW 3.4) is ONO.

其他以 Medtronic Navigation, Inc. 為申請人之記錄

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K253379Stealth AXiS 頭部臨床應用 K253395Stealth AXiS™ 鼻喉科臨床應用 K253391視覺熱激光應用器系統 (9735559)；視覺熱激光應用器系統 (9735560)；視覺熱激光應用器系統 (9735561)K253381Stealth AXiS™ 外科系統搭配 Stealth AXiS™ 脊椎臨床應用 K251282StealthStation S8 頸椎軟體 K242464Stealth™脊椎夾具；ModuLeX™柄座安裝

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相關器械（代碼：ONO）

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。

K262315神經消融系統Monteris Medical K260976神經消融系統Monteris Medical K253391視覺熱激光應用器系統 (9735559)；視覺熱激光應用器系統 (9735560)；視覺熱激光應用器系統 (9735561)Medtronic Navigation, Inc.K251298移動雷射單元（1001-N2）；熱導工作站（1100-N1）；雷射施用器（4012-N5、4017-N2、4017-N4）；MR 引導器（4013-N6）Clinical Laserthermia Systems, AB K250307視覺化V2 MRI導引激光消融系統（9736422）Medtronic Navigation K240877蒙特里斯醫療神經刀系統Monteris Medical,

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