Vscan Extend
K-Number: K161588 · 2016-08-31
Decision Date2016-08-31
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vscan Extend is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-08-31 under approval number K161588. 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 2016-08-31. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161588.
When was Vscan Extend approved by the FDA?
Vscan Extend received FDA 510(k) clearance on 2016-08-31, under approval number K161588.
What company makes Vscan Extend?
Vscan Extend is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
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 & Primary Care Diagnostics, LLC
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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.