MR 引导聚焦超声系统
PMA编号：P150038 · 2026-09-16
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申请人Insightec
决定日期2026-09-16
PMA 编号P150038
产品代码POH
设备分类第3类
医疗专科U
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
器械摘要
MR-guided focused ultrasound system is the device name listed in this FDA 510(k) record. The listed applicant is Insightec. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code POH. It was reviewed by the NE advisory panel.
常见问题
What is the MR-guided focused ultrasound system?
MR-guided focused ultrasound system is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Insightec.
When did MR-guided focused ultrasound system receive FDA 510(k) clearance?
The clearance date for MR-guided focused ultrasound system can be found in the official FDA records.
MR引导聚焦超声系统列出的申请人是谁？
The FDA 510(k) record lists Insightec as the applicant. This does not by itself establish the device manufacturer.
什么是MR引导聚焦超声系统的FDA产品代码？
FDA产品代码为MR引导聚焦超声系统的是POH。
相关临床试验
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官方来源
在 FDA 数据库中查看 →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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