Emission Computed Tomography System
FDA 510(k) clearance K182938 · decided 2018-12-18
Clearance details
- K-number
- K182938
- Device name
- Emission Computed Tomography System
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-23
- Decision date
- 2018-12-18
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- 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 |
|---|---|---|
| uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be recall (Z-2799-2020) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-08-13 |