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FDA 510(k)

uAngio AVIVA CX

K-Number: K243376 · 2025-04-28

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2025-04-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uAngio AVIVA CX is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-04-28 under 510(k) 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. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243376.

When did uAngio AVIVA CX receive FDA 510(k) clearance?

uAngio AVIVA CX received FDA 510(k) clearance on 2025-04-28, under 510(k) number K243376.

Who is the listed applicant for uAngio AVIVA CX?

The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uAngio AVIVA CX?

The FDA product code for uAngio AVIVA CX is OWB.

Other records listing Shanghai United Imaging Healthcare Co., Ltd. as applicant

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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.

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