i-CAT FLX V series / KaVo 3D eXam+ V series
K-Number: K162085 · 2016-11-10
ApplicantImaging Sciences International
Decision Date2016-11-10
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
i-CAT FLX V series / KaVo 3D eXam+ V series is a medical device manufactured by Imaging Sciences International. It received FDA 510(k) clearance on 2016-11-10 under approval number K162085. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the i-CAT FLX V series / KaVo 3D eXam+ V series?
i-CAT FLX V series / KaVo 3D eXam+ V series is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Imaging Sciences International. The 510(k) number is K162085.
When was i-CAT FLX V series / KaVo 3D eXam+ V series approved by the FDA?
i-CAT FLX V series / KaVo 3D eXam+ V series received FDA 510(k) clearance on 2016-11-10, under approval number K162085.
What company makes i-CAT FLX V series / KaVo 3D eXam+ V series?
i-CAT FLX V series / KaVo 3D eXam+ V series is manufactured by Imaging Sciences International.
What is the FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series?
The FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series is OAS.
Related Devices (Code: OAS)
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.