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FDA 510(k)

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

Número K: K171977 · 2018-08-02

RequerenteHinacom Software and Technology, Ltd.
Data da decisão2018-08-02
Código do produtoLLZ
Comité consultivoRA
DecisãoSubstantially Equivalent

Resumo do dispositivo

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Hinacom Software and Technology, Ltd.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K171977. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Hinacom Software and Technology, Ltd.. The 510(k) number is K171977.

When did miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer receive FDA 510(k) clearance?

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer received FDA 510(k) clearance on 2018-08-02, under 510(k) number K171977.

Who is the listed applicant for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

The FDA 510(k) record lists Hinacom Software and Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

The FDA product code for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is LLZ.

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