HistoSonics® 规划工具
K号: K252947 · 2026-05-29
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器械摘要
HistoSonics® Planning Tool is the device name listed in this FDA 510(k) record. The listed applicant is HistoSonics, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252947. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HistoSonics® Planning Tool?
HistoSonics® Planning Tool is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is HistoSonics, Inc.. The 510(k) number is K252947.
When did HistoSonics® Planning Tool receive FDA 510(k) clearance?
HistoSonics® Planning Tool received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252947.
Who is the listed applicant for HistoSonics® Planning Tool?
The FDA 510(k) record lists HistoSonics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HistoSonics® Planning Tool?
The FDA product code for HistoSonics® Planning Tool is QTZ.
相关临床试验
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列明HistoSonics, Inc.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。
相关器械（代码：QTZ）
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。
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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