X-VIEW，IMAGEN
K号: K151137 · 2016-06-07
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器械摘要
X-VIEW, IMAGEN is the device name listed in this FDA 510(k) record. The listed applicant is Edlen Imaging, LLC. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K151137. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the X-VIEW, IMAGEN?
X-VIEW, IMAGEN is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Edlen Imaging, LLC. The 510(k) number is K151137.
When did X-VIEW, IMAGEN receive FDA 510(k) clearance?
X-VIEW, IMAGEN received FDA 510(k) clearance on 2016-06-07, under 510(k) number K151137.
Who is the listed applicant for X-VIEW, IMAGEN?
The FDA 510(k) record lists Edlen Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-VIEW, IMAGEN?
The FDA product code for X-VIEW, IMAGEN is OAS.
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：OAS）
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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