FDA 510(k)

AV Cardiac CT

N.º K: K260169 · 2026-03-05

SolicitantePhilips Medical Systems Nederland B.V.

Fecha de decisión2026-03-05

Código de productoJAK

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

AV Cardiac CT 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 2026-03-05 under 510(k) number K260169. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AV Cardiac CT?

AV Cardiac CT is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K260169.

When did AV Cardiac CT receive FDA 510(k) clearance?

AV Cardiac CT received FDA 510(k) clearance on 2026-03-05, under 510(k) number K260169.

Who is the listed applicant for AV Cardiac CT?

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 AV Cardiac CT?

The FDA product code for AV Cardiac CT is JAK.

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Otros registros que enlistan a Philips Medical Systems Nederland B.V. como solicitante

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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.