FDA 510(k)

FlexView Diagnostic (v1.1.20)

Número K: K233226 · 2024-01-17

Data da decisão2024-01-17

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

FlexView Diagnostic (v1.1.20) is the device name listed in this FDA 510(k) record. The listed applicant is Radical Imaging, LLC. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233226. 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 FlexView Diagnostic (v1.1.20)?

FlexView Diagnostic (v1.1.20) is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Radical Imaging, LLC. The 510(k) number is K233226.

When did FlexView Diagnostic (v1.1.20) receive FDA 510(k) clearance?

FlexView Diagnostic (v1.1.20) received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233226.

Who is the listed applicant for FlexView Diagnostic (v1.1.20)?

The FDA 510(k) record lists Radical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexView Diagnostic (v1.1.20)?

The FDA product code for FlexView Diagnostic (v1.1.20) is LLZ.

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Fonte oficial

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