Asimov-MKS 成像系统
K号: K192761 · 2020-01-17
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器械摘要
Asimov-MKS Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Onlume, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192761. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Asimov-MKS Imaging System?
Asimov-MKS Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Onlume, Inc.. The 510(k) number is K192761.
When did Asimov-MKS Imaging System receive FDA 510(k) clearance?
Asimov-MKS Imaging System received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192761.
Who is the listed applicant for Asimov-MKS Imaging System?
The FDA 510(k) record lists Onlume, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Asimov-MKS Imaging System?
The FDA product code for Asimov-MKS Imaging System is IZI.
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相关器械（代码：IZI）
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
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