FDA 510(k)

IC-Flow™ Imaging System 2.0

Número K: K243645 · 2025-09-22

Data da decisão2025-09-22

Código do produtoIZI

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

IC-Flow™ Imaging System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Green GmbH. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K243645. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IC-Flow™ Imaging System 2.0?

IC-Flow™ Imaging System 2.0 is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Diagnostic Green GmbH. The 510(k) number is K243645.

When did IC-Flow™ Imaging System 2.0 receive FDA 510(k) clearance?

IC-Flow™ Imaging System 2.0 received FDA 510(k) clearance on 2025-09-22, under 510(k) number K243645.

Who is the listed applicant for IC-Flow™ Imaging System 2.0?

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

What is the FDA product code for IC-Flow™ Imaging System 2.0?

The FDA product code for IC-Flow™ Imaging System 2.0 is IZI.

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