Elekta Unity
K-Number: K212114 · 2021-10-01
ApplicantElekta Solutions AB
Decision Date2021-10-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Elekta Unity is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2021-10-01 under approval number K212114. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elekta Unity?
Elekta Unity is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Elekta Solutions AB. The 510(k) number is K212114.
When was Elekta Unity approved by the FDA?
Elekta Unity received FDA 510(k) clearance on 2021-10-01, under approval number K212114.
What company makes Elekta Unity?
Elekta Unity is manufactured by Elekta Solutions AB.
What is the FDA product code for Elekta Unity?
The FDA product code for Elekta Unity is IYE.
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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.