FDA 510(k)

Site~Rite Halcyon Diagnostic Ultrasound System

K-번호: K170870 · 2017-07-06

결정일2017-07-06

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Chison Medical Imaging Co., Ltd.를 신청인으로 등재한 기타 기록

K170374SonoBook Series Diagnostic Ultrasound System K162172EBit Series Diagnostic Ultrasound System

관련 기기 (코드: IYN)

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