FDA 510(k)

Site~Rite Halcyon Diagnostic Ultrasound System

K-Nummer: K170870 · 2017-07-06

AntragstellerChison Medical Imaging Co., Ltd.

Entscheidungsdatum2017-07-06

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Site~Rite Halcyon Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Chison Medical Imaging Co., Ltd.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K170870. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Site~Rite Halcyon Diagnostic Ultrasound System?

Site~Rite Halcyon Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Chison Medical Imaging Co., Ltd.. The 510(k) number is K170870.

When did Site~Rite Halcyon Diagnostic Ultrasound System receive FDA 510(k) clearance?

Site~Rite Halcyon Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-07-06, under 510(k) number K170870.

Who is the listed applicant for Site~Rite Halcyon Diagnostic Ultrasound System?

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

What is the FDA product code for Site~Rite Halcyon Diagnostic Ultrasound System?

The FDA product code for Site~Rite Halcyon Diagnostic Ultrasound System is IYN.

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