消融系统，高强度聚焦超声（HIFU），MR引导
PMA编号：P110039 · 2018-08-16
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申请人Insightec
决定日期2018-08-16
PMA 编号P110039
产品代码NRZ
设备分类第3类
医疗专科U
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
器械摘要
Ablation system, high intensity focused ultrasound (HIFU), MR-guided is the device name listed in this FDA 510(k) record. The listed applicant is Insightec. It received FDA 510(k) clearance on 2018-08-16. The device is classified under product code NRZ. It was reviewed by the SU advisory panel.
常见问题
What is the Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
Ablation system, high intensity focused ultrasound (HIFU), MR-guided is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Insightec.
When did Ablation system, high intensity focused ultrasound (HIFU), MR-guided receive FDA 510(k) clearance?
The clearance date for Ablation system, high intensity focused ultrasound (HIFU), MR-guided can be found in the official FDA records.
Who is the listed applicant for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
The FDA 510(k) record lists Insightec as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
The FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided is NRZ.
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官方来源
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