SonoVision Ultrasound Imaging System
K-Number: K192388 · 2020-03-12
Decision Date2020-03-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SonoVision Ultrasound Imaging System is a medical device manufactured by Tissue Differentiation Intelligence, LLC. It received FDA 510(k) clearance on 2020-03-12 under approval number K192388. 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 SonoVision Ultrasound Imaging System?
SonoVision Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-12. It is manufactured by Tissue Differentiation Intelligence, LLC. The 510(k) number is K192388.
When was SonoVision Ultrasound Imaging System approved by the FDA?
SonoVision Ultrasound Imaging System received FDA 510(k) clearance on 2020-03-12, under approval number K192388.
What company makes SonoVision Ultrasound Imaging System?
SonoVision Ultrasound Imaging System is manufactured by Tissue Differentiation Intelligence, LLC.
What is the FDA product code for SonoVision Ultrasound Imaging System?
The FDA product code for SonoVision Ultrasound Imaging 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.