ARIETTA x10
K-Number: K231941 · 2023-11-20
Decision Date2023-11-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ARIETTA x10 is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-11-20 under approval number K231941. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARIETTA x10?
ARIETTA x10 is a medical device that received FDA 510(k) clearance on 2023-11-20. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231941.
When was ARIETTA x10 approved by the FDA?
ARIETTA x10 received FDA 510(k) clearance on 2023-11-20, under approval number K231941.
What company makes ARIETTA x10?
ARIETTA x10 is manufactured by FUJIFILM Healthcare Americas Corporation.
What is the FDA product code for ARIETTA x10?
The FDA product code for ARIETTA x10 is IYN.
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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.