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FDA 510(k)

Planmed XFI

K号: K250318 · 2025-09-26

申请人Planmed OY
决定日期2025-09-26
产品代码SFV
咨询委员会RA
决定实质等同

器械摘要

Planmed XFI is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K250318. The device is classified under product code SFV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Planmed XFI?

Planmed XFI is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Planmed OY. The 510(k) number is K250318.

When did Planmed XFI receive FDA 510(k) clearance?

Planmed XFI received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250318.

Who is the listed applicant for Planmed XFI?

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

What is the FDA product code for Planmed XFI?

The FDA product code for Planmed XFI is SFV.

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

列明Planmed OY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。

K211720Planmed Clarity 2D, Planmed Clarify SK213278Planmed VerityK192317Planmed Clarity 2D和Clarity SK180918Planmed VerityK163328Planmed Clarity

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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