FDA 510(k)

CT/MR 兼容 M.A.C. 间质性妇科模板

K号: K150979 · 2016-05-31

决定日期2016-05-31

产品代码JAQ

咨询委员会RA

决定实质等同

器械摘要

CT/MR Compatible M.A.C. Interstitial GYN Template 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 2016-05-31 under 510(k) number K150979. 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/MR Compatible M.A.C. Interstitial GYN Template?

CT/MR Compatible M.A.C. Interstitial GYN Template is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K150979.

When did CT/MR Compatible M.A.C. Interstitial GYN Template receive FDA 510(k) clearance?

CT/MR Compatible M.A.C. Interstitial GYN Template received FDA 510(k) clearance on 2016-05-31, under 510(k) number K150979.

Who is the listed applicant for CT/MR Compatible M.A.C. Interstitial GYN Template?

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/MR Compatible M.A.C. Interstitial GYN Template?

The FDA product code for CT/MR Compatible M.A.C. Interstitial GYN Template is JAQ.

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 K200221CT 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

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。