uCT 530, uCT 550
FDA 510(k) clearance K181414 · decided 2018-08-14
Clearance details
- K-number
- K181414
- Device name
- uCT 530, uCT 550
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-30
- Decision date
- 2018-08-14
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 5 recall (Z-0217-2026) | UIH Technologies LLC | 2025-10-21 |
| Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 5 recall (Z-0218-2026) | UIH Technologies LLC | 2025-10-21 |
| Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Prod recall (Z-2704-2020) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-27 |
| Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Prod recall (Z-2705-2020) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-27 |
| Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uC recall (Z-2641-2020) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-20 |