FDA 510(k)

Visualase V2 MRI引导激光消融系统（9736422）

K号: K250307 · 2025-05-29

决定日期2025-05-29

产品代码ONO

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决定实质等同

器械摘要

Visualase V2 MRI-guided Laser Ablation System (9736422) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K250307. 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 V2 MRI-guided Laser Ablation System (9736422)?

Visualase V2 MRI-guided Laser Ablation System (9736422) is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Medtronic Navigation. The 510(k) number is K250307.

When did Visualase V2 MRI-guided Laser Ablation System (9736422) receive FDA 510(k) clearance?

Visualase V2 MRI-guided Laser Ablation System (9736422) received FDA 510(k) clearance on 2025-05-29, under 510(k) number K250307.

Who is the listed applicant for Visualase V2 MRI-guided Laser Ablation System (9736422)?

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

What is the FDA product code for Visualase V2 MRI-guided Laser Ablation System (9736422)?

The FDA product code for Visualase V2 MRI-guided Laser Ablation System (9736422) is ONO.

列明Medtronic Navigation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。

K212397StealthStation S8颅骨v2.0 K211442StealthStation椎弓根夹具 K201327NavLock Trackers K193579PlasmaBlade X 3.0S LIGHT K182104NavLock Trackers, Robotic Reference Frame K180816Ziehm RFD 3D 跟踪器

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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 K240877Monteris Medical NeuroBlate 系统Monteris Medical,K214125TRANBERG 热导治疗系统Clinical Laserthermia Systems, AB

官方来源

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