hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K-Number: K214084 · 2022-01-20
ApplicantCefla S.C.
Decision Date2022-01-20
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2022-01-20 under approval number K214084. 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 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device that received FDA 510(k) clearance on 2022-01-20. It is manufactured by Cefla S.C.. The 510(k) number is K214084.
When was hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS approved by the FDA?
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS received FDA 510(k) clearance on 2022-01-20, under approval number K214084.
What company makes hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is manufactured by Cefla S.C..
What is the FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?
The FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is OAS.
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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.