SonoSite X-Porte Ultrasound System
K-Number: K171437 · 2017-06-12
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2017-06-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SonoSite X-Porte Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2017-06-12 under approval number K171437. 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 X-Porte Ultrasound System?
SonoSite X-Porte Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-06-12. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K171437.
When was SonoSite X-Porte Ultrasound System approved by the FDA?
SonoSite X-Porte Ultrasound System received FDA 510(k) clearance on 2017-06-12, under approval number K171437.
What company makes SonoSite X-Porte Ultrasound System?
SonoSite X-Porte Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for SonoSite X-Porte Ultrasound System?
The FDA product code for SonoSite X-Porte 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.