Vscan Extend
K-Number: K180995 · 2018-06-25
Decision Date2018-06-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vscan Extend is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2018-06-25 under approval number K180995. 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 Vscan Extend?
Vscan Extend is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K180995.
When was Vscan Extend approved by the FDA?
Vscan Extend received FDA 510(k) clearance on 2018-06-25, under approval number K180995.
What company makes Vscan Extend?
Vscan Extend is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vscan Extend?
The FDA product code for Vscan Extend is IYN.
Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics
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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.