FDA 510(k)

SuniIQ Digital Radiography System

N.º K: K162585 · 2016-11-04

Fecha de decisión2016-11-04

Código de productoMUH

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

SuniIQ Digital Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Suni Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162585. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SuniIQ Digital Radiography System?

SuniIQ Digital Radiography System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Suni Medical Imaging, Inc.. The 510(k) number is K162585.

When did SuniIQ Digital Radiography System receive FDA 510(k) clearance?

SuniIQ Digital Radiography System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162585.

Who is the listed applicant for SuniIQ Digital Radiography System?

The FDA 510(k) record lists Suni Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SuniIQ Digital Radiography System?

The FDA product code for SuniIQ Digital Radiography System is MUH.

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