FDA 510(k)

Visualase MRI引导激光消融系统（SW 3.4）

K号: K211269 · 2022-01-07

决定日期2022-01-07

产品代码ONO

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决定实质等同

器械摘要

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.

常见问题

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.

列明Medtronic Navigation, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253379Stealth AXiS颅部临床应用 K253395Stealth AXiS™ ENT临床应用 K253391Visualase 冷却激光治疗仪系统（9735559）；Visualase 冷却激光治疗仪系统（9735560）；Visualase 冷却激光治疗仪系统（9735561）K253381Stealth AXiS™手术系统及Stealth AXiS™脊柱临床应用 K251282StealthStation S8脊柱软件 K242464Stealth® 脊柱夹具；ModuLeX® 股轴安装座

查看所有 24 个设备 →

相关器械（代码：ONO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262315NeuroBlate 系统Monteris Medical K260976NeuroBlate 系统Monteris Medical K253391Visualase 冷却激光治疗仪系统（9735559）；Visualase 冷却激光治疗仪系统（9735560）；Visualase 冷却激光治疗仪系统（9735561）Medtronic Navigation, Inc.K251298移动激光单元（1001-N2）；Thermoguide 工作站（1100-N1）；激光应用器（4012-N5，4017-N2，4017-N4）；MR 引导器（4013-N6）Clinical Laserthermia Systems, AB K250307Visualase V2 MRI引导激光消融系统（9736422）Medtronic Navigation K240877Monteris Medical NeuroBlate 系统Monteris Medical,

官方来源

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