Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
K-Number: K191007 · 2019-10-25
ApplicantSupersonic Imagine
Decision Date2019-10-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is a medical device manufactured by Supersonic Imagine. It received FDA 510(k) clearance on 2019-10-25 under approval number K191007. 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 MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is a medical device that received FDA 510(k) clearance on 2019-10-25. It is manufactured by Supersonic Imagine. The 510(k) number is K191007.
When was Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems approved by the FDA?
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems received FDA 510(k) clearance on 2019-10-25, under approval number K191007.
What company makes Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is manufactured by Supersonic Imagine.
What is the FDA product code for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?
The FDA product code for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 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.