FDA 510(k)

Hermes Medical Imaging Suite v5.6

N.º K: K153056 · 2016-06-01

Fecha de decisión2016-06-01

Código de productoKPS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hermes Medical Imaging Suite v5.6 is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K153056. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hermes Medical Imaging Suite v5.6?

Hermes Medical Imaging Suite v5.6 is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K153056.

When did Hermes Medical Imaging Suite v5.6 receive FDA 510(k) clearance?

Hermes Medical Imaging Suite v5.6 received FDA 510(k) clearance on 2016-06-01, under 510(k) number K153056.

Who is the listed applicant for Hermes Medical Imaging Suite v5.6?

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

What is the FDA product code for Hermes Medical Imaging Suite v5.6?

The FDA product code for Hermes Medical Imaging Suite v5.6 is KPS.

Ensayos clínicos relacionados

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Otros registros que enlistan a Hermes Medical Solutions AB como solicitante

K253835Affinity K252477Hybrid Viewer (00859873006240)K243919Voxel Dosimetry (00859873006226)K241364Hybrid Viewer (00859873006189)K202882Affinity K193152Affinity

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: KPS)

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.