uWS-Angio Basic
K-Number: K243632 · 2025-05-12
Decision Date2025-05-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uWS-Angio Basic is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-05-12 under approval number K243632. 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 uWS-Angio Basic?
uWS-Angio Basic is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K243632.
When was uWS-Angio Basic approved by the FDA?
uWS-Angio Basic received FDA 510(k) clearance on 2025-05-12, under approval number K243632.
What company makes uWS-Angio Basic?
uWS-Angio Basic is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uWS-Angio Basic?
The FDA product code for uWS-Angio Basic is LLZ.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: LLZ)
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.