uWS-Angio Basic
FDA 510(k) K243632 · Shanghai United Imaging Healthcare Co., Ltd.
510(k) numberK243632
Submission
- Device name
- uWS-Angio Basic
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN - Received
- November 25, 2024
- Decision date
- May 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253173 | uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | 11/26/2025SE |
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Questions and answers
When was uWS-Angio Basic cleared by the FDA?
uWS-Angio Basic (K243632) received a 510(k) decision of Substantially Equivalent on May 12, 2025, 168 days after the submission was received.
What is the product code of K243632?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.