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FDA 510(k)

Exablate Model 2100V1，Exablate前列腺系统，Exablate MRgFUS，Exablate 2100V1型号3.0

K号: K231378 · 2023-10-30

申请人Insightec, Ltd.
决定日期2023-10-30
产品代码PLP
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Insightec, Ltd.. It received FDA 510(k) clearance on 2023-10-30 under 510(k) number K231378. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Insightec, Ltd.. The 510(k) number is K231378.

When did Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 receive FDA 510(k) clearance?

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 received FDA 510(k) clearance on 2023-10-30, under 510(k) number K231378.

Who is the listed applicant for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

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

What is the FDA product code for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

The FDA product code for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is PLP.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：PLP）

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。

K251910Focal One®Edap Technomed, Inc.K240296图尔萨普罗系统（Pad-105）Profound Medical, Inc.K230692TULSA-PRO系统Profound Medical, Inc.K211858TULSA-PRO系统Profound Medical, Inc.K212150Exablate前列腺系统Insightec, Inc.K202286图尔萨-普罗系统Profound Medical, Inc.

官方来源

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