麦克拉伦质子治疗系统X射线成像系统
K号: K181498 · 2018-12-10
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器械摘要
X-ray Imaging System for the McLaren Proton Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Ehmetdx, LLC. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K181498. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the X-ray Imaging System for the McLaren Proton Treatment System?
X-ray Imaging System for the McLaren Proton Treatment System is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Ehmetdx, LLC. The 510(k) number is K181498.
When did X-ray Imaging System for the McLaren Proton Treatment System receive FDA 510(k) clearance?
X-ray Imaging System for the McLaren Proton Treatment System received FDA 510(k) clearance on 2018-12-10, under 510(k) number K181498.
Who is the listed applicant for X-ray Imaging System for the McLaren Proton Treatment System?
The FDA 510(k) record lists Ehmetdx, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-ray Imaging System for the McLaren Proton Treatment System?
The FDA product code for X-ray Imaging System for the McLaren Proton Treatment System is LHN.
相关临床试验
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。
相关器械（代码：LHN）
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。
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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。
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