Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
K-Number: K173021 · 2018-01-09
ApplicantSupersonic Imagine
Decision Date2018-01-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems is a medical device manufactured by Supersonic Imagine. It received FDA 510(k) clearance on 2018-01-09 under approval number K173021. 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 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems?
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems is a medical device that received FDA 510(k) clearance on 2018-01-09. It is manufactured by Supersonic Imagine. The 510(k) number is K173021.
When was Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems approved by the FDA?
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems received FDA 510(k) clearance on 2018-01-09, under approval number K173021.
What company makes Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems?
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems is manufactured by Supersonic Imagine.
What is the FDA product code for Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems?
The FDA product code for Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems is IYN.
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Other Devices by Supersonic Imagine
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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.