BI IMAGE-X EVOLUTION
K-Number: K160458 · 2016-06-20
Decision Date2016-06-20
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BI IMAGE-X EVOLUTION is a medical device manufactured by Radiotecnologia Industrial S.A. DE C.V.. It received FDA 510(k) clearance on 2016-06-20 under approval number K160458. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BI IMAGE-X EVOLUTION?
BI IMAGE-X EVOLUTION is a medical device that received FDA 510(k) clearance on 2016-06-20. It is manufactured by Radiotecnologia Industrial S.A. DE C.V.. The 510(k) number is K160458.
When was BI IMAGE-X EVOLUTION approved by the FDA?
BI IMAGE-X EVOLUTION received FDA 510(k) clearance on 2016-06-20, under approval number K160458.
What company makes BI IMAGE-X EVOLUTION?
BI IMAGE-X EVOLUTION is manufactured by Radiotecnologia Industrial S.A. DE C.V..
What is the FDA product code for BI IMAGE-X EVOLUTION?
The FDA product code for BI IMAGE-X EVOLUTION is EHD.
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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.