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FDA 510(k)

CT F/S/D兼容应用器（Fletcher），HDR兼容串联和椭圆形应用器（Henschke），HDR CT兼容分裂环应用器，分段阴道应用器，HDR迈阿密应用器HDR近距离放射治疗应用器，2/3子宫内膜应用器套装，CT HDR环和串联应用器带直肠拉钩

K号: K200221 · 2020-02-28

申请人Mick Radio-Nuclear Instruments, Inc.
决定日期2020-02-28
产品代码JAQ
咨询委员会RA
决定实质等同

器械摘要

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor is the device name listed in this FDA 510(k) record. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K200221. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor?

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K200221.

When did CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor receive FDA 510(k) clearance?

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor received FDA 510(k) clearance on 2020-02-28, under 510(k) number K200221.

Who is the listed applicant for CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor?

The FDA 510(k) record lists Mick Radio-Nuclear Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor?

The FDA product code for CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor is JAQ.

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Mick Radio-Nuclear Instruments, 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。

K230155Mick Valencia 施用器套装K150979CT/MR 兼容 M.A.C. 间质性妇科模板

相关器械（代码：JAQ）

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。

K262383LumenCare AzureNucletron B.V.K252717MAASTRO 直肠应用器套装Varian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884引导阿胡斯应用器套装Varian Medical SystemsK250299CT/ MR 连续和椭圆形套装Varian Medical Systems, Inc.K250289腔内/间质系统Varian Medical Systems

官方来源

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