Vitrea CT Dual Energy Image View
K-Number: K161157 · 2016-11-03
ApplicantVital Images, Inc.
Decision Date2016-11-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vitrea CT Dual Energy Image View is a medical device manufactured by Vital Images, Inc.. It received FDA 510(k) clearance on 2016-11-03 under approval number K161157. 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 Vitrea CT Dual Energy Image View?
Vitrea CT Dual Energy Image View is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by Vital Images, Inc.. The 510(k) number is K161157.
When was Vitrea CT Dual Energy Image View approved by the FDA?
Vitrea CT Dual Energy Image View received FDA 510(k) clearance on 2016-11-03, under approval number K161157.
What company makes Vitrea CT Dual Energy Image View?
Vitrea CT Dual Energy Image View is manufactured by Vital Images, Inc..
What is the FDA product code for Vitrea CT Dual Energy Image View?
The FDA product code for Vitrea CT Dual Energy Image View 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.