SRT-100+
K号: K173425 · 2018-03-23
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器械摘要
SRT-100+ 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 2018-03-23 under 510(k) number K173425. 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 SRT-100+?
SRT-100+ is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K173425.
When did SRT-100+ receive FDA 510(k) clearance?
SRT-100+ received FDA 510(k) clearance on 2018-03-23, under 510(k) number K173425.
Who is the listed applicant for SRT-100+?
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 SRT-100+?
The FDA product code for SRT-100+ is JAD.
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.K182641Sensus IORT 系统Sensus Healthcare, Inc.K190255Sensus Healthcare TVM 气球应用器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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