SonoSite iViz Ultrasound System
K-Number: K161119 · 2016-05-13
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-05-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SonoSite iViz Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-05-13 under approval number K161119. 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 SonoSite iViz Ultrasound System?
SonoSite iViz Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K161119.
When was SonoSite iViz Ultrasound System approved by the FDA?
SonoSite iViz Ultrasound System received FDA 510(k) clearance on 2016-05-13, under approval number K161119.
What company makes SonoSite iViz Ultrasound System?
SonoSite iViz Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for SonoSite iViz Ultrasound System?
The FDA product code for SonoSite iViz 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.