FDA 510(k)

TAIMedImg DeepMets

Número K: K250427 · 2025-05-28

RequerenteTaiwan Medical Imaging Co., Ltd.

Data da decisão2025-05-28

Código do produtoQKB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

TAIMedImg DeepMets is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Medical Imaging Co., Ltd.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K250427. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TAIMedImg DeepMets?

TAIMedImg DeepMets is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Taiwan Medical Imaging Co., Ltd.. The 510(k) number is K250427.

When did TAIMedImg DeepMets receive FDA 510(k) clearance?

TAIMedImg DeepMets received FDA 510(k) clearance on 2025-05-28, under 510(k) number K250427.

Who is the listed applicant for TAIMedImg DeepMets?

The FDA 510(k) record lists Taiwan Medical Imaging Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAIMedImg DeepMets?

The FDA product code for TAIMedImg DeepMets is QKB.

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Fonte oficial

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