VesselIQ Xpress
K-Number: K200626 · 2021-02-16
ApplicantGE Medical Systems SCS
Decision Date2021-02-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VesselIQ Xpress is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2021-02-16 under approval number K200626. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VesselIQ Xpress?
VesselIQ Xpress is a medical device that received FDA 510(k) clearance on 2021-02-16. It is manufactured by GE Medical Systems SCS. The 510(k) number is K200626.
When was VesselIQ Xpress approved by the FDA?
VesselIQ Xpress received FDA 510(k) clearance on 2021-02-16, under approval number K200626.
What company makes VesselIQ Xpress?
VesselIQ Xpress is manufactured by GE Medical Systems SCS.
What is the FDA product code for VesselIQ Xpress?
The FDA product code for VesselIQ Xpress is JAK.
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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.