uAngio AVIVA CX
K-Number: K243376 · 2025-04-28
Decision Date2025-04-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uAngio AVIVA CX is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-04-28 under approval number K243376. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uAngio AVIVA CX?
uAngio AVIVA CX is a medical device that received FDA 510(k) clearance on 2025-04-28. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243376.
When was uAngio AVIVA CX approved by the FDA?
uAngio AVIVA CX received FDA 510(k) clearance on 2025-04-28, under approval number K243376.
What company makes uAngio AVIVA CX?
uAngio AVIVA CX is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uAngio AVIVA CX?
The FDA product code for uAngio AVIVA CX is OWB.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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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.