Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
K-Number: K160620 · 2016-03-30
ApplicantVisaris D.O.O. Belgrade
Decision Date2016-03-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is a medical device manufactured by Visaris D.O.O. Belgrade. It received FDA 510(k) clearance on 2016-03-30 under approval number K160620. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?
Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is a medical device that received FDA 510(k) clearance on 2016-03-30. It is manufactured by Visaris D.O.O. Belgrade. The 510(k) number is K160620.
When was Visaris Vision® (Vision C, Vision U. Vision V, Vision X) approved by the FDA?
Visaris Vision® (Vision C, Vision U. Vision V, Vision X) received FDA 510(k) clearance on 2016-03-30, under approval number K160620.
What company makes Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?
Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is manufactured by Visaris D.O.O. Belgrade.
What is the FDA product code for Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?
The FDA product code for Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is KPR.
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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.