Acteon Imaging Suite
K-Number: K192165 · 2020-02-11
ApplicantDe Gotzen S.R.L.
Decision Date2020-02-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Acteon Imaging Suite is a medical device manufactured by De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-02-11 under approval number K192165. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Acteon Imaging Suite?
Acteon Imaging Suite is a medical device that received FDA 510(k) clearance on 2020-02-11. It is manufactured by De Gotzen S.R.L.. The 510(k) number is K192165.
When was Acteon Imaging Suite approved by the FDA?
Acteon Imaging Suite received FDA 510(k) clearance on 2020-02-11, under approval number K192165.
What company makes Acteon Imaging Suite?
Acteon Imaging Suite is manufactured by De Gotzen S.R.L..
What is the FDA product code for Acteon Imaging Suite?
The FDA product code for Acteon Imaging Suite is LLZ.
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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.