FDA 510(k)

iDMS 数据管理系统

K号: K161144 · 2016-06-24

决定日期2016-06-24

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

iDMS Data Management 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 K161144. 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 iDMS Data Management System?

iDMS Data Management 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 K161144.

When did iDMS Data Management System receive FDA 510(k) clearance?

iDMS Data Management System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161144.

Who is the listed applicant for iDMS Data Management 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 iDMS Data Management System?

The FDA product code for iDMS Data Management 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 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。

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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。