FDA 510(k)

Radixact治疗输送系统运动跟踪和补偿功能

K号: K182687 · 2018-11-23

决定日期2018-11-23

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery 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 2018-11-23 under 510(k) number K182687. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System?

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Accuray Incorporated. The 510(k) number is K182687.

When did Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System receive FDA 510(k) clearance?

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System received FDA 510(k) clearance on 2018-11-23, under 510(k) number K182687.

Who is the listed applicant for Motion Tracking and Compensation Feature for the Radixact Treatment Delivery 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 Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System?

The FDA product code for Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System is IYE.

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 K171837TomoTherapy治疗输送系统带iDMS K171086Accuray Precision治疗计划系统。K161144iDMS 数据管理系统

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官方来源

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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。