FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
uWS-Angio
K Number: K250040
·
Decision Sep 12, 2025
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
83
Review Days
247
Basic Information
- Device Name
- uWS-Angio
- K Number
- K250040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Date Received
- January 8, 2025
- Decision Date
- September 12, 2025
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Shanghai United Imaging Healthcare Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260113 | uMR Astra | May 22, 2026 | Substantially Equivalent |
| K253077 | uOmnispace.MR | Apr 22, 2026 | Substantially Equivalent |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Apr 3, 2026 | Substantially Equivalent |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Feb 13, 2026 | Substantially Equivalent |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Jan 20, 2026 | Substantially Equivalent |
| K252000 | uDR Arria & uDR Aris | Nov 26, 2025 | Substantially Equivalent |
| K252371 | uMR 680 | Sep 25, 2025 | Substantially Equivalent |
| K250045 | uWS-Angio Pro | Sep 24, 2025 | Substantially Equivalent |
| K251167 | uDR Aurora CX | Sep 19, 2025 | Substantially Equivalent |
| K250246 | uMR Jupiter | Aug 5, 2025 | Substantially Equivalent |