FDA 510(k)

DeepTek CXR Analyzer v1.0

Número K: K231001 · 2023-10-05

RequerenteDeeptek Medical Imaging Pvt, Ltd.

Data da decisão2023-10-05

Código do produtoMYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

DeepTek CXR Analyzer v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Deeptek Medical Imaging Pvt, Ltd.. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K231001. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DeepTek CXR Analyzer v1.0?

DeepTek CXR Analyzer v1.0 is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Deeptek Medical Imaging Pvt, Ltd.. The 510(k) number is K231001.

When did DeepTek CXR Analyzer v1.0 receive FDA 510(k) clearance?

DeepTek CXR Analyzer v1.0 received FDA 510(k) clearance on 2023-10-05, under 510(k) number K231001.

Who is the listed applicant for DeepTek CXR Analyzer v1.0?

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

What is the FDA product code for DeepTek CXR Analyzer v1.0?

The FDA product code for DeepTek CXR Analyzer v1.0 is MYN.

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