FDA 510(k)

Galen™ Second Read™

Número K: K241232 · 2025-01-24

Data da decisão2025-01-24

Código do produtoQPN

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Galen™ Second Read™ is the device name listed in this FDA 510(k) record. The listed applicant is Ibex Medical Analytics , Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241232. The device is classified under product code QPN. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Galen™ Second Read™?

Galen™ Second Read™ is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Ibex Medical Analytics , Ltd.. The 510(k) number is K241232.

When did Galen™ Second Read™ receive FDA 510(k) clearance?

Galen™ Second Read™ received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241232.

Who is the listed applicant for Galen™ Second Read™?

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

What is the FDA product code for Galen™ Second Read™?

The FDA product code for Galen™ Second Read™ is QPN.

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