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FDA 510(k)

uWS-Angio Pro

K-Number: K250045 · 2025-09-24

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2025-09-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uWS-Angio Pro 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 2025-09-24 under 510(k) number K250045. 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 Pro?

uWS-Angio Pro is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K250045.

When did uWS-Angio Pro receive FDA 510(k) clearance?

uWS-Angio Pro received FDA 510(k) clearance on 2025-09-24, under 510(k) number K250045.

Who is the listed applicant for uWS-Angio Pro?

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 uWS-Angio Pro?

The FDA product code for uWS-Angio Pro is LLZ.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261427uMI Panvivo (uMI Panvivo M)K260113uMR AstraK253077uOmnispace.MRK260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253173uCT 780 with uWS-CT-Dual Energy Analysis

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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