FDA 510(k)

Galaxy R Digital Radiography Upgrade

N.º K: K172435 · 2017-10-13

SolicitanteMedien International Co, Ltd.

Fecha de decisión2017-10-13

Código de productoMQB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Galaxy R Digital Radiography Upgrade is the device name listed in this FDA 510(k) record. The listed applicant is Medien International Co, Ltd.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K172435. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Galaxy R Digital Radiography Upgrade?

Galaxy R Digital Radiography Upgrade is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Medien International Co, Ltd.. The 510(k) number is K172435.

When did Galaxy R Digital Radiography Upgrade receive FDA 510(k) clearance?

Galaxy R Digital Radiography Upgrade received FDA 510(k) clearance on 2017-10-13, under 510(k) number K172435.

Who is the listed applicant for Galaxy R Digital Radiography Upgrade?

The FDA 510(k) record lists Medien International Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Galaxy R Digital Radiography Upgrade?

The FDA product code for Galaxy R Digital Radiography Upgrade is MQB.

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Fuente oficial

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