FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
uWS-CT
K Number: K173001
·
Decision Nov 7, 2018
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
19
Review Days
406
Basic Information
- Device Name
- uWS-CT
- K Number
- K173001
- 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
- September 27, 2017
- Decision Date
- November 7, 2018
- 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 | ||
|---|---|---|---|
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | May 16, 2025 | Substantially Equivalent |
| K243376 | uAngio AVIVA CX | Apr 28, 2025 | Substantially Equivalent |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Dec 12, 2024 | Substantially Equivalent |
| K242515 | uDR 380i Pro | Oct 10, 2024 | Substantially Equivalent |
| K241585 | uMI Panorama | Aug 30, 2024 | Substantially Equivalent |
| K230758 | uMR 570 | May 18, 2023 | Substantially Equivalent |
| K220332 | uMR Omega with uWS-MR-MRS | Oct 27, 2022 | Substantially Equivalent |
| K210001 | HYPER AiR | Apr 30, 2021 | Substantially Equivalent |
| K210418 | HYPER Focus | Apr 9, 2021 | Substantially Equivalent |
| K201540 | uMR570 | Jul 6, 2020 | Substantially Equivalent |