SuperSonic HepaVu
K-Number: K242223 · 2024-09-20
ApplicantSupersonic Imagine
Decision Date2024-09-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SuperSonic HepaVu is a medical device manufactured by Supersonic Imagine. It received FDA 510(k) clearance on 2024-09-20 under approval number K242223. 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 SuperSonic HepaVu?
SuperSonic HepaVu is a medical device that received FDA 510(k) clearance on 2024-09-20. It is manufactured by Supersonic Imagine. The 510(k) number is K242223.
When was SuperSonic HepaVu approved by the FDA?
SuperSonic HepaVu received FDA 510(k) clearance on 2024-09-20, under approval number K242223.
What company makes SuperSonic HepaVu?
SuperSonic HepaVu is manufactured by Supersonic Imagine.
What is the FDA product code for SuperSonic HepaVu?
The FDA product code for SuperSonic HepaVu 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.