FDA 510(k)

System Sophi

Número K: K250501 · 2025-11-14

Data da decisão2025-11-14

Código do produtoHQC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

System Sophi is the device name listed in this FDA 510(k) record. The listed applicant is This AG. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K250501. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the System Sophi?

System Sophi is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is This AG. The 510(k) number is K250501.

When did System Sophi receive FDA 510(k) clearance?

System Sophi received FDA 510(k) clearance on 2025-11-14, under 510(k) number K250501.

Who is the listed applicant for System Sophi?

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

What is the FDA product code for System Sophi?

The FDA product code for System Sophi is HQC.

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