FDA 510(k)

Medical image processing software

Número K: K220910 · 2022-08-11

RequerenteHangzhou Deepwise & League of PHD Technology Co., Ltd.

Data da decisão2022-08-11

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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