Vitrea CT Brain Perfusion
K-Number: K181247 · 2018-11-20
ApplicantVital Images, Inc.
Decision Date2018-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vitrea CT Brain Perfusion is a medical device manufactured by Vital Images, Inc.. It received FDA 510(k) clearance on 2018-11-20 under approval number K181247. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vitrea CT Brain Perfusion?
Vitrea CT Brain Perfusion is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Vital Images, Inc.. The 510(k) number is K181247.
When was Vitrea CT Brain Perfusion approved by the FDA?
Vitrea CT Brain Perfusion received FDA 510(k) clearance on 2018-11-20, under approval number K181247.
What company makes Vitrea CT Brain Perfusion?
Vitrea CT Brain Perfusion is manufactured by Vital Images, Inc..
What is the FDA product code for Vitrea CT Brain Perfusion?
The FDA product code for Vitrea CT Brain Perfusion is LLZ.
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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.