UC-5000 移动X射线设备
K号: K163063 · 2016-12-12
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器械摘要
UC-5000 Mobile X-Ray is the device name listed in this FDA 510(k) record. The listed applicant is Source-Ray, Inc.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K163063. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UC-5000 Mobile X-Ray?
UC-5000 Mobile X-Ray is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Source-Ray, Inc.. The 510(k) number is K163063.
When did UC-5000 Mobile X-Ray receive FDA 510(k) clearance?
UC-5000 Mobile X-Ray received FDA 510(k) clearance on 2016-12-12, under 510(k) number K163063.
Who is the listed applicant for UC-5000 Mobile X-Ray?
The FDA 510(k) record lists Source-Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UC-5000 Mobile X-Ray?
The FDA product code for UC-5000 Mobile X-Ray is IZL.
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：IZL）
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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