FDA 510(k)

PerfusiX-Imaging

Número K: K254180 · 2026-07-24

Data da decisão2026-07-24

Código do produtoOWN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PerfusiX-Imaging is the device name listed in this FDA 510(k) record. The listed applicant is LIMIS Development B.V.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K254180. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PerfusiX-Imaging?

PerfusiX-Imaging is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is LIMIS Development B.V.. The 510(k) number is K254180.

When did PerfusiX-Imaging receive FDA 510(k) clearance?

PerfusiX-Imaging received FDA 510(k) clearance on 2026-07-24, under 510(k) number K254180.

Who is the listed applicant for PerfusiX-Imaging?

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

What is the FDA product code for PerfusiX-Imaging?

The FDA product code for PerfusiX-Imaging is OWN.

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