SonoSite Edge II Ultrasound System
K-Number: K153626 · 2016-01-20
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2016-01-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SonoSite Edge II Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-01-20 under approval number K153626. 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 Edge II Ultrasound System?
SonoSite Edge II Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K153626.
When was SonoSite Edge II Ultrasound System approved by the FDA?
SonoSite Edge II Ultrasound System received FDA 510(k) clearance on 2016-01-20, under approval number K153626.
What company makes SonoSite Edge II Ultrasound System?
SonoSite Edge II Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for SonoSite Edge II Ultrasound System?
The FDA product code for SonoSite Edge II 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.