Optellum 虚拟结节诊所，Optellum 软件，Optellum 平台
K号: K202300 · 2021-03-05
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器械摘要
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is the device name listed in this FDA 510(k) record. The listed applicant is Optellum, Ltd.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K202300. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Optellum, Ltd.. The 510(k) number is K202300.
When did Optellum Virtual Nodule Clinic, Optellum software, Optellum platform receive FDA 510(k) clearance?
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202300.
Who is the listed applicant for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?
The FDA 510(k) record lists Optellum, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?
The FDA product code for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is POK.
相关临床试验
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相关器械（代码：POK）
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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