FDA 510(k)

Precision Treatment Planning System

K号: K161136 · 2016-06-24

决定日期2016-06-24

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

Precision Treatment Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161136. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Precision Treatment Planning System?

Precision Treatment Planning System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Accuray Incorporated. The 510(k) number is K161136.

When did Precision Treatment Planning System receive FDA 510(k) clearance?

Precision Treatment Planning System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161136.

Who is the listed applicant for Precision Treatment Planning System?

The FDA 510(k) record lists Accuray Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Treatment Planning System?

The FDA product code for Precision Treatment Planning System is MUJ.

列明Accuray Incorporated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。

K223159Radixact治疗输送系统 K212794Accuray Precision治疗计划系统。K202412ClearRT 螺旋 kVCT 用于 Radixact 治疗递送系统 K182687Radixact治疗输送系统运动跟踪和补偿功能 K171837TomoTherapy治疗输送系统带iDMS K171086Accuray Precision治疗计划系统。

查看所有 9 个设备 →

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。