FDA 510(k)

Image Guidance System for Radiotherapy

N.º K: K192405 · 2020-05-01

SolicitanteJiangsu Rayer Medical Technology Co., Ltd.

Fecha de decisión2020-05-01

Código de productoIYE

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Image Guidance System for Radiotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rayer Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192405. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Image Guidance System for Radiotherapy?

Image Guidance System for Radiotherapy is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Jiangsu Rayer Medical Technology Co., Ltd.. The 510(k) number is K192405.

When did Image Guidance System for Radiotherapy receive FDA 510(k) clearance?

Image Guidance System for Radiotherapy received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192405.

Who is the listed applicant for Image Guidance System for Radiotherapy?

The FDA 510(k) record lists Jiangsu Rayer Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Guidance System for Radiotherapy?

The FDA product code for Image Guidance System for Radiotherapy is IYE.

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Fuente oficial

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