FDA 510(k)

自动肺结节检测

K号: K201560 · 2021-08-31

决定日期2021-08-31

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

Auto Lung Nodule Detection is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K201560. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Auto Lung Nodule Detection?

Auto Lung Nodule Detection is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K201560.

When did Auto Lung Nodule Detection receive FDA 510(k) clearance?

Auto Lung Nodule Detection received FDA 510(k) clearance on 2021-08-31, under 510(k) number K201560.

Who is the listed applicant for Auto Lung Nodule Detection?

FDA 510(k)记录将三星电子株式会社列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Auto Lung Nodule Detection?

The FDA product code for Auto Lung Nodule Detection is MYN.

列明Samsung Electronics Co., Ltd.为申报人的其他记录

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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