FDA 510(k)

MRIdian Linac系统

K号: K181989 · 2019-02-20

决定日期2019-02-20

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

MRIdian Linac System is the device name listed in this FDA 510(k) record. The listed applicant is Viewray, Incorporated. It received FDA 510(k) clearance on 2019-02-20 under 510(k) number K181989. 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 MRIdian Linac System?

MRIdian Linac System is a medical device that received FDA 510(k) clearance on 2019-02-20. The listed applicant is Viewray, Incorporated. The 510(k) number is K181989.

When did MRIdian Linac System receive FDA 510(k) clearance?

MRIdian Linac System received FDA 510(k) clearance on 2019-02-20, under 510(k) number K181989.

Who is the listed applicant for MRIdian Linac System?

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

What is the FDA product code for MRIdian Linac System?

The FDA product code for MRIdian Linac System is IYE.

列明Viewray, 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。

K212958MRIdian Linac系统 K170751MRIdian Linac系统带138-叶片准直器 K162393ViewRay (MRIdian) 线束系统

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。