FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
uCT 780 with uWS-CT-Dual Energy Analysis
K Number: K253173
·
Decision Jan 20, 2026
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
83
Review Days
116
Basic Information
- Device Name
- uCT 780 with uWS-CT-Dual Energy Analysis
- K Number
- K253173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Date Received
- September 26, 2025
- Decision Date
- January 20, 2026
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology
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 |
| 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 |
| K250246 | uMR Jupiter | Aug 5, 2025 | Substantially Equivalent |