FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
uMR 680
K Number: K243397
·
Decision Jul 16, 2025
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
83
Review Days
258
Basic Information
- Device Name
- uMR 680
- K Number
- K243397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Date Received
- October 31, 2024
- Decision Date
- July 16, 2025
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by Shanghai United Imaging Healthcare Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K250040 | uWS-Angio | Sep 12, 2025 | Substantially Equivalent |