医用辐射剂量学系统microSTARii
K号: K192196 · 2019-12-27
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器械摘要
Medical Radiation Dosimetry System microSTARii is the device name listed in this FDA 510(k) record. The listed applicant is Landauer. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192196. 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 Medical Radiation Dosimetry System microSTARii?
Medical Radiation Dosimetry System microSTARii is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Landauer. The 510(k) number is K192196.
When did Medical Radiation Dosimetry System microSTARii receive FDA 510(k) clearance?
Medical Radiation Dosimetry System microSTARii received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192196.
Who is the listed applicant for Medical Radiation Dosimetry System microSTARii?
The FDA 510(k) record lists Landauer as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Radiation Dosimetry System microSTARii?
The FDA product code for Medical Radiation Dosimetry System microSTARii is IYE.
相关临床试验
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相关器械（代码：IYE）
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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