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FDA 510(k)

医用图像处理软件

K号: K220910 · 2022-08-11

决定日期2022-08-11
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

Medical image processing software is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Deepwise & League of PHD Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K220910. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medical image processing software?

Medical image processing software is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Hangzhou Deepwise & League of PHD Technology Co., Ltd.. The 510(k) number is K220910.

When did Medical image processing software receive FDA 510(k) clearance?

Medical image processing software received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220910.

Who is the listed applicant for Medical image processing software?

The FDA 510(k) record lists Hangzhou Deepwise & League of PHD Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical image processing software?

The FDA product code for Medical image processing software is JAK.

相关临床试验

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相关器械(代码:JAK)

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