Sensus IORT 系统
K号: K182641 · 2019-02-21
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器械摘要
Sensus IORT System is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under 510(k) number K182641. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sensus IORT System?
Sensus IORT System is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K182641.
When did Sensus IORT System receive FDA 510(k) clearance?
Sensus IORT System received FDA 510(k) clearance on 2019-02-21, under 510(k) number K182641.
Who is the listed applicant for Sensus IORT System?
The FDA 510(k) record lists Sensus Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sensus IORT System?
The FDA product code for Sensus IORT System is JAD.
相关临床试验
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列明Sensus Healthcare, 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：JAD）
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。
K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM（700）；以及附件（INTRABEAM SMART Stand，INTRABEAM SMART 球形应用器，INTRABEAM 球形尺寸套装，INTRABEAM 针状应用器）Carl Zeiss Meditec, AGK230611X80 / RADiant / 光电疗法系统（RADiant Aura）Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM 气球应用器Sensus Healthcare, Inc.K173425SRT-100+Sensus Healthcare, Inc.
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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