伽马Tile
K号: K190839 · 2020-01-23
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器械摘要
GammaTile is the device name listed in this FDA 510(k) record. The listed applicant is Gt Medical Technologies. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K190839. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GammaTile?
GammaTile is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Gt Medical Technologies. The 510(k) number is K190839.
When did GammaTile receive FDA 510(k) clearance?
GammaTile received FDA 510(k) clearance on 2020-01-23, under 510(k) number K190839.
Who is the listed applicant for GammaTile?
The FDA 510(k) record lists Gt Medical Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GammaTile?
The FDA product code for GammaTile is KXK.
相关临床试验
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列明Gt Medical Technologies为申报人的其他记录
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相关器械（代码：KXK）
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。
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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