Site~Rite Halcyon Diagnostic Ultrasound System
K-Number: K170870 · 2017-07-06
ApplicantChison Medical Imaging Co., Ltd.
Decision Date2017-07-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Site~Rite Halcyon Diagnostic Ultrasound System is a medical device manufactured by Chison Medical Imaging Co., Ltd.. It received FDA 510(k) clearance on 2017-07-06 under approval number K170870. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Chison Medical Imaging Co., Ltd.. The 510(k) number is K170870.
When was Site~Rite Halcyon Diagnostic Ultrasound System approved by the FDA?
Site~Rite Halcyon Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-07-06, under approval number K170870.
What company makes Site~Rite Halcyon Diagnostic Ultrasound System?
Site~Rite Halcyon Diagnostic Ultrasound System is manufactured by Chison Medical Imaging Co., Ltd..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.