Aquilion Exceed LB
K-Number: K211828 · 2021-09-10
ApplicantCanon Medical Systems Corporation
Decision Date2021-09-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Aquilion Exceed LB is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-09-10 under approval number K211828. 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 Aquilion Exceed LB?
Aquilion Exceed LB is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K211828.
When was Aquilion Exceed LB approved by the FDA?
Aquilion Exceed LB received FDA 510(k) clearance on 2021-09-10, under approval number K211828.
What company makes Aquilion Exceed LB?
Aquilion Exceed LB is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Aquilion Exceed LB?
The FDA product code for Aquilion Exceed LB 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.