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FDA 510(k)

INTRABEAM（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）

K号: K241174 · 2025-01-10

申请人Carl Zeiss Meditec, AG
决定日期2025-01-10
产品代码JAD
咨询委员会RA
决定实质等同

器械摘要

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241174. 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 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)?

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K241174.

When did INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) receive FDA 510(k) clearance?

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241174.

Who is the listed applicant for INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)?

FDA 510(k)记录显示卡尔蔡司医疗技术股份公司（Carl Zeiss Meditec, AG）为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)?

The FDA product code for INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) is JAD.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Carl Zeiss Meditec, AG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。

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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, LLCK230611X80 / 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.K182641Sensus IORT 系统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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