FDA 510(k)

Philips IntelliSite Pathology Solution 5.1

N.º K: K243871 · 2025-03-06

SolicitantePhilips Medical Systems Nederland B.V.

Fecha de decisión2025-03-06

Código de productoPSY

Comité asesorPA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Philips IntelliSite Pathology Solution 5.1 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243871. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Philips IntelliSite Pathology Solution 5.1?

Philips IntelliSite Pathology Solution 5.1 is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K243871.

When did Philips IntelliSite Pathology Solution 5.1 receive FDA 510(k) clearance?

Philips IntelliSite Pathology Solution 5.1 received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243871.

Who is the listed applicant for Philips IntelliSite Pathology Solution 5.1?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips IntelliSite Pathology Solution 5.1?

The FDA product code for Philips IntelliSite Pathology Solution 5.1 is PSY.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.